Statistical Archives - World News: Entertainment, lifestyle, Health, Technology https://toptechblitz.com.ng/tag/statistical/ Mon, 15 Jan 2024 09:29:05 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 https://i0.wp.com/toptechblitz.com.ng/wp-content/uploads/2024/01/cropped-Blue-and-Red-Abstract-Breaking-News-Politics-Logo-1.png?fit=32%2C32&ssl=1 Statistical Archives - World News: Entertainment, lifestyle, Health, Technology https://toptechblitz.com.ng/tag/statistical/ 32 32 213894740 Associate Principal Scientist, Statistical Programmer | Oncology (Hybrid) https://toptechblitz.com.ng/associate-principal-scientist-statistical-programmer-oncology-hybrid/ https://toptechblitz.com.ng/associate-principal-scientist-statistical-programmer-oncology-hybrid/#respond Mon, 15 Jan 2024 09:29:05 +0000 https://toptechblitz.com.ng/associate-principal-scientist-statistical-programmer-oncology-hybrid/ Job title: Associate Principal Scientist, Statistical Programmer | Oncology (Hybrid) Company: MSD Job description: Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory [...]

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Job title: Associate Principal Scientist, Statistical Programmer | Oncology (Hybrid)

Company: MSD

Job description: Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.

The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.

The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.

For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Primary Activities:

Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.

Maintain and manage a project plan including resource forecasting.

Coordinate the activities of a global programming team that includes outsource provider staff.

Membership on departmental strategic initiative teams

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years SAS programming experience in a clinical trial environment.

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment.

Department Required Skills and Experience:

Excellent interpersonal skills and ability to negotiate and collaborate effectively.

Excellent written, oral, and presentation skills

Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

Position Specific Required Skills and Experience:

Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.

Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.

US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.

Designs and develops complex programming algorithms.

Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts.

Familiarity with clinical data management concepts

Experience in CDISC and ADaM standards

Demonstrated success in the assurance of deliverable quality and process compliance.

Strategic thinking – ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

Ability to anticipate stakeholder requirements.

** Preferred Skills and Experience:

Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)

Experience providing technical and/or programming guidance and mentoring to colleagues.

Ability and interest to work across cultures and geographies.

Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.

Experience developing and managing a project plan using Microsoft Project or similar package.

Active in professional societies

Experience in process improvement.

#EligibleforERP
BARDS2020
SPJOBS
VETJOBS

#EBRG

NOTICE FOR INTERNAL APPLICANTS

In accordance with all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

to request this role’s pay range.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range: $130,960.00 – $206,200.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed .

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: Yes

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: 1st – Day

Valid Driving License: No

Hazardous Material(s): n/a

Expected salary:

Location: Gwynedd, PA – Wales

Job date: Fri, 29 Dec 2023 23:31:51 GMT

Apply for the job now!

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Senior Statistical Programmer II – FSP https://toptechblitz.com.ng/senior-statistical-programmer-ii-fsp/ https://toptechblitz.com.ng/senior-statistical-programmer-ii-fsp/#respond Sun, 31 Dec 2023 10:37:57 +0000 https://toptechblitz.com.ng/senior-statistical-programmer-ii-fsp/ Job title: Senior Statistical Programmer II – FSP Company: Warman O’Brien Job description: 4449 Posted: 22/12/2023 Competitive Home Based , United Kingdom Permanent Senior Statistical Programmer II – FSP | Leading CRO | UK | Home Based | Industry leading CRO who are on a mission to improve health have a new opportunity for a [...]

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Job title: Senior Statistical Programmer II – FSP

Company: Warman O’Brien

Job description: 4449 Posted: 22/12/2023

  • Competitive
  • Home Based , United Kingdom
  • Permanent

Senior Statistical Programmer II – FSP | Leading CRO | UK | Home Based |

Industry leading CRO who are on a mission to improve health have a new opportunity for a Senor Statistical Programmer II to join them in the UK or across Europe. This is a fantastic opportunity to join an organisation with a truly collaborative and winning culture with a focus on flexible working and work-life balance. This is an urgent opportunity for an experienced Statistical Programmer II looking for a mix of hands-on technical programming and study lead.

As a Senior II/Principal Programmer with FSP, you will act as the lead programmer, project lead, or project oversight lead, dedicated to one client and overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting.

What you will be doing:

  • Act as the lead programmer or project lead on studies of significant complexity.
  • Work directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.
  • Assume leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
  • Independently create, execute, maintain, and validate programs that transfer data across multiple data management systems or operating systems, combine data from a variety of sources and structures, generates and store summary data from a variety of sources, generate reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.
  • Manage and document assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
  • Increase knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
  • Provide training, guidance, and project leadership to junior team members.
  • Provides input into bidding process as requested.

What you will need:

  • Bachelor’s degree or equivalent in computer science, mathematics, statistics, data science/analytics, or other relevant scientific and at least 8 years’ experience in hands-on programming, with lead programming experience.
  • ADaM, TLF programming, DMC support and regulatory support experience.
  • Proven experience as an independent, lead programmer.
  • Experience programming complex analysis datasets and outputs (efficacy, complex lab and regulatory requests).
  • eCRT and define.xml knowledge.
  • Strong written and verbal communications skills to effectively interface with teams and clients globally, including proficiency in the English language.
  • Demonstrated leadership ability and ability to work on a multi-disciplinary project team, training, and mentoring others.
  • Capable of providing quality control review for statistical programming and identifying solutions and process improvements.
  • Able to independently and effectively organise and manage multiple assignments with challenging timelines.
  • Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.

What’s in it for you:

  • Work for a global organisation with a local feel who are dedicated to supporting and fostering work-life balance and flexibility.
  • Access to award winning learning and development program ensuring you reach your full potential.
  • Fully home based with all equipment provided.
  • Very competitive salary plus extensive benefits package based around employee’s health and well-being.
  • 10% annual performance-related bonus.
  • Immediate interviews available.

What to do next:
If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the Senior Statistical Programmer II onboard as soon as possible.

Not what you’re looking for?
Please contact Jo Fornaciari on 0330 335 9476 for a confidential discussion about potential opportunities.

Expected salary:

Location: United Kingdom

Job date: Fri, 22 Dec 2023 23:17:18 GMT

Apply for the job now!

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Principal Statistical Programmer https://toptechblitz.com.ng/principal-statistical-programmer/ https://toptechblitz.com.ng/principal-statistical-programmer/#respond Sat, 30 Dec 2023 10:15:55 +0000 https://toptechblitz.com.ng/principal-statistical-programmer/ Job title: Principal Statistical Programmer Company: Alexion Pharmaceuticals Job description: Location: Mississauga, Canada; Dublin, Ireland Job reference: R-172045 Date posted: 07/11/2023 This is what you will do: The Principal Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and ADaM specifications, as well Tables, [...]

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Job title: Principal Statistical Programmer

Company: Alexion Pharmaceuticals

Job description: Location: Mississauga, Canada; Dublin, Ireland Job reference: R-172045 Date posted: 07/11/2023

This is what you will do:

The Principal Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and ADaM specifications, as well Tables, Listings, and Figures (“TLFs”) for analysis of efficacy data. He/she will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. He/she will serve as a Programming Lead and represent Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams. The Principal Statistical Programmer will act as a mentor to all other Statistical Programmers. He/she must demonstrate, at a minimum, an expert ability to comprehensively integrate statistical concepts with SAS Programming in the most efficient and effective manner.

You will be responsible for:

  • Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
  • Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
  • Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs based on Protocol SAP.
  • Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.
  • Supervise/manage external vendors and contract programmers.
  • Oversee progress of programming activities.
  • Review, maintain, and approve protocol specific documents as necessary.
  • Provide guidance and mentoring to peer and junior-level Programmers.
  • Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
  • Contribute ideas and thoughts towards the optimization of standard operating procedures.
  • Lead team meetings when appropriate.
  • Any other activities as required.

You will need to have:

  • Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics or another related discipline
  • Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
  • Proven ability to:
  • Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
  • Independently and collaboratively resolve problems
  • Clearly communicate processes and standards with management and team members

Expected salary:

Location: Mississauga, ON

Job date: Fri, 08 Dec 2023 23:07:22 GMT

Apply for the job now!

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Senior Statistical Programmer II https://toptechblitz.com.ng/senior-statistical-programmer-ii/ https://toptechblitz.com.ng/senior-statistical-programmer-ii/#respond Sun, 24 Dec 2023 14:36:55 +0000 https://toptechblitz.com.ng/senior-statistical-programmer-ii/ Job title: Senior Statistical Programmer II Company: Warman O’Brien Job description: 4432 Posted: 04/12/2023 Competitive , United Kingdom Permanent Principal Statistical Programmer | Home-Based Position | Outstanding CRO | UK | Europe I am currently collaborating with a leading Contract Research Organisation (CRO) dedicated to expanding its Statistical Programming team. We are seeking a skilled [...]

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Job title: Senior Statistical Programmer II

Company: Warman O’Brien

Job description: 4432 Posted: 04/12/2023

  • Competitive
  • , United Kingdom
  • Permanent

Principal Statistical Programmer | Home-Based Position | Outstanding CRO | UK | Europe

I am currently collaborating with a leading Contract Research Organisation (CRO) dedicated to expanding its Statistical Programming team. We are seeking a skilled Principal Statistical Programmer to join this award-winning organisation. Committed to excellence, the company prioritises investing in its people, recognising them as the cornerstone of its achievements.

In the role of Principal Statistical Programmer, you will lead multiple studies of varying complexity and scale, collaborating with top experts in the industry. This opportunity also involves actively contributing to the planned technology expansion, offering exposure to languages like R. Additionally, you will play a pivotal role in shaping the future technology roadmap, particularly in areas such as technology, standardization, automation, and process enhancements.

Key Responsibilities:

  • Lead Phase II & III studies in collaboration with diverse clients.
  • Program statistical analyses/reports, emphasizing CDISC ADaM programming.
  • Lead teams to deliver high-quality SAS programming outputs across all project deliverables.
  • Mentor and train junior staff members.
  • Provide analysis programming (ADaM/TLF) and ADaM specification development and support.
  • Create, validate, execute, and generate statistical programs for listings, safety, and efficacy outputs.
  • Develop and review analysis dataset specifications.
  • Utilize and modify project or department level macros.
  • Act as a mentor, contributing to the training of junior staff.

Requirements:

  • BSc or MSc degree in Statistics, Mathematics, or Computer Science.
  • Experience leading Phase II and/or Phase III studies.
  • Proficiency in creating and validating CDISC ADaM analysis datasets and TLFs.
  • Strong SAS programming skills.
  • Preferably, experience with Pinnacle 21.
  • Demonstrated professional leadership and exceptional communication skills.

What You’ll Receive:

  • Opportunity to work with a globally recognized organization, awarded World’s Best Employer & Best Employer for Diversity 2022.
  • Emphasis on work-life balance and flexibility.
  • Fully home-based with provided equipment.
  • Competitive salary and comprehensive total reward benefits package, including an annual bonus.
  • Access to excellent training and development plans.
  • Tailored career development opportunities.
  • Fast one-stage interview process with full support provided.

Next Steps:

If you find this opportunity intriguing, please reach out to me for more information on:
+443303359475
esme@warmanobrien.com

Expected salary:

Location: United Kingdom

Job date: Wed, 06 Dec 2023 04:52:06 GMT

Apply for the job now!

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Senior Statistical Programmer https://toptechblitz.com.ng/senior-statistical-programmer/ https://toptechblitz.com.ng/senior-statistical-programmer/#respond Sat, 23 Dec 2023 15:12:20 +0000 https://toptechblitz.com.ng/senior-statistical-programmer/ Job title: Senior Statistical Programmer Company: Warman O’Brien Job description: 4430 Posted: 04/12/2023 Competitive , United Kingdom Permanent Senior Statistical Programmer II | Home-Based Position | Outstanding CRO | UK | Europe I am currently collaborating with a leading Contract Research Organization (CRO) dedicated to expanding its Statistical Programming team. We are seeking a skilled [...]

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Job title: Senior Statistical Programmer

Company: Warman O’Brien

Job description: 4430 Posted: 04/12/2023

  • Competitive
  • , United Kingdom
  • Permanent

Senior Statistical Programmer II | Home-Based Position | Outstanding CRO | UK | Europe

I am currently collaborating with a leading Contract Research Organization (CRO) dedicated to expanding its Statistical Programming team. We are seeking a skilled Senior Statistical Programmer II to join this award-winning organisation. Committed to excellence, the company prioritizes investing in its people, recognising them as the cornerstone of its achievements.

In the role of Senior Statistical Programmer II, you will lead multiple studies of varying complexity and scale, collaborating with top experts in the industry. This opportunity also involves actively contributing to the planned technology expansion, offering exposure to languages like R. Additionally, you will play a pivotal role in shaping the future technology roadmap, particularly in areas such as technology, standardization, automation, and process enhancements.

Key Responsibilities:

  • Lead Phase II & III studies in collaboration with diverse clients.
  • Program statistical analyses/reports, emphasizing CDISC ADaM programming.
  • Lead teams to deliver high-quality SAS programming outputs across all project deliverables.
  • Mentor and train junior staff members.
  • Provide analysis programming (ADaM/TLF) and ADaM specification development and support.
  • Create, validate, execute, and generate statistical programs for listings, safety, and efficacy outputs.
  • Develop and review analysis dataset specifications.
  • Utilize and modify project or department level macros.
  • Act as a mentor, contributing to the training of junior staff.

Requirements:

  • BSc or MSc degree in Statistics, Mathematics, or Computer Science.
  • Experience leading Phase II and/or Phase III studies.
  • Proficiency in creating and validating CDISC ADaM analysis datasets and TLFs.
  • Strong SAS programming skills.
  • Preferably, experience with Pinnacle 21.
  • Demonstrated professional leadership and exceptional communication skills.

What You’ll Receive:

  • Opportunity to work with a globally recognized organization, awarded World’s Best Employer & Best Employer for Diversity 2022.
  • Emphasis on work-life balance and flexibility.
  • Fully home-based with provided equipment.
  • Competitive salary and comprehensive total reward benefits package, including an annual bonus.
  • Access to excellent training and development plans.
  • Tailored career development opportunities.
  • Fast one-stage interview process with full support provided.

Next Steps:

If you find this opportunity intriguing, please reach out to me for more information on:
+443303359475
esme@warmanobrien.com

Expected salary:

Location: United Kingdom

Job date: Wed, 06 Dec 2023 05:38:17 GMT

Apply for the job now!

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(Senior) Manager* Statistical Programming – REMOTE https://toptechblitz.com.ng/senior-manager-statistical-programming-remote/ https://toptechblitz.com.ng/senior-manager-statistical-programming-remote/#respond Mon, 04 Dec 2023 17:10:58 +0000 https://toptechblitz.com.ng/senior-manager-statistical-programming-remote/ Job title: (Senior) Manager* Statistical Programming – REMOTE Company: Proclinical Job description: Salary: Highly Competitive Salary Job type: Permanent * Discipline: Statistics, Informatics, Programming * Location: United States Alamogordo, USA Posting date: 15 Nov 2023 Reference: SS.MH.57592 Proclinical is seeking a remote (Senior) Manager* Statistical Programming for a cutting-edge biotech company. Must be eligible to [...]

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Job title: (Senior) Manager* Statistical Programming – REMOTE

Company: Proclinical

Job description: Salary: Highly Competitive Salary

  • Job type:

Permanent * Discipline:

Statistics, Informatics, Programming * Location:

United States

Alamogordo, USA

Posting date: 15 Nov 2023

Reference: SS.MH.57592

Proclinical is seeking a remote (Senior) Manager* Statistical Programming for a cutting-edge biotech company.

Must be eligible to work in the US.

Job Responsibilities:

  • Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting
  • Independently perform or oversee the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries
  • Anticipate resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project
  • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements
  • Participate in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios; develop tools for efficient production and verification of derived datasets, e.g., SDTM and ADaM, and TLFs
  • Provide functional expertise in the development and implementation of centralized clinical data repository, clinical data dictionary, and operational data dictionary
  • Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools
  • Provide programming support to the regulatory submissions including data submission package and define.xml development

Skills and Requirements:

  • BSc in Statistics, Mathematics, Computer Science, or related discipline, advanced degree preferred
  • 5+ years (3+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
  • Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
  • Good understanding of FDA, EMA, ICH, and global regulations and guidelines
  • Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
  • Oncology or Infectious Disease therapeutic areas and submission experience is preferred
  • Project management experience, detail-oriented, and strong organizational and communication skills in English (written and Spoken)
  • Ability to work in a fast-paced, dynamic team environment as well as strong analytical and problem solving skills

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at +(1) 323-306-2409 or m.hermiz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MH2

Expected salary:

Location: USA

Job date: Fri, 17 Nov 2023 05:47:06 GMT

Apply for the job now!

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Sr Statistical Programmer – FSP model https://toptechblitz.com.ng/sr-statistical-programmer-fsp-model/ https://toptechblitz.com.ng/sr-statistical-programmer-fsp-model/#respond Sun, 19 Nov 2023 10:57:32 +0000 https://toptechblitz.com.ng/sr-statistical-programmer-fsp-model/ Job title: Sr Statistical Programmer – FSP model Company: Syneos Health Job description: Updated: Yesterday Location: North America-United States, United States Job ID: 23006899-USA Description Senior Statistical Programmer – FSP model Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights [...]

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Job title: Sr Statistical Programmer – FSP model

Company: Syneos Health

Job description: Updated: Yesterday

Location: North America-United States, United States

Job ID: 23006899-USA

Description

Senior Statistical Programmer – FSP model

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job responsibilities

  • Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
  • Works to ensure that outputs meet quality standards and project requirements.
  • Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
  • Keeps project team members informed of programming progress and issues requiring their attention.
  • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
  • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
  • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
  • Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
  • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
  • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
  • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
  • Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
  • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
  • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
  • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
  • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
  • Transfers deliverables.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required

Qualifications

What we’re looking for

  • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
  • Excellent written and verbal communication skills.
  • Ability to read, write, speak and understand English.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about .

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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Location: USA

Job date: Sat, 11 Nov 2023 02:20:38 GMT

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