Job description: 4241 Posted: 02/11/2023

• 80000
• UK, United Kingdom
• Permanent

Senior / Principal Biostatistician – Biotech – UK – Remote / Hybrid – UK

Overview:

We are working exclusively for a small biotech who are looking for a Senior or Principal Statistician to join their exciting, innovative team, specialising in Immunotherapy. As a senior member of a cross-functional team, you will be responsible for the oversight and management of biostatistics activities to ensure high quality design, analysis and interpretation of the company’s sponsored clinical trials.

Your Key Responsibilities Will Include:

• Statistical contribution to the design, analysis and interpretation of clinical studies, including the writing the statistical sections of protocols, SAPs and study related activities.
• Oversight and review of vendor statistical activities, with accountability for study level timeliness and quality of statistical deliveries
• Act as key contact for biostatistics vendors to ensure effective communication between biotech and the biostatistics vendors.
• Provide statistical insight and exploratory analyses of completed and ongoing company studies.
• Provide effective communication and visualisation of data and statistical analyses within company and support for publications and presentations.
• Communicate progress and identify risks and issues arising on clinical trials to the Director of Clinical Operations and other company development team members as appropriate.

Who They Are Looking For Experience :
You’ll have strong people skills and be an expert team player, with demonstrated ability to be a part of multi-functional teams. You’ll have an entrepreneurial mindset and the ability to bring creative solutions to challenges. As a natural networker, you’ll forge strong relationships and alliances at all levels, internally & externally. You will also be highly motivated, passionate and energetic with an action oriented, results driven approach to everything you do.

Your Skills, Knowledge & Experience

• Postgraduate degree in statistics or related discipline.
• Substantial experience of clinical biostatistics in the pharmaceutical/biotech industry
• Experience of managing outsourced biostatistics activities
• Experience of dermatology/rheumatology clinical trials would be an advantage.
• Robust knowledge of GCP and related regulatory standards for clinical biostatistics governing clinical trials in the UK, EU & USA
• Programming experience with SAS and/or R
• Excellent oral and written communication skills
• Ability to interpret, process and present data in innovative ways to meet the needs of multiple stakeholders
• Highly organised, able to prioritise work, work well under pressure and meet deadlines
• Independent, self-starter with a proactive, problem solving approach
• Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants
• Ability to see complex projects to completion, and to work on a broad range of tasks within a project

What To Do Next?
If this opportunity is of interest, please apply now with your CV as they are looking to arrange interviews soon.

Not what you are looking for? Please contact Aimee Weston at / +44 7806 790645 for a confidential discussion about potential opportunities.

Expected salary:

Location: United Kingdom

Job date: Sat, 04 Nov 2023 00:41:06 GMT

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Job description: Job Title: Web Accessibility Specialist (Hybrid Onsite)

Location: Denver, CO

Duration: 6 Months

Pay Rate: $65/hr

Time Line: 1/19/2024

Note: *Please note we are unable to provide H1B visa sponsorship* Look for US Citizens or Green Cards Only

Job Description:

We are in search of a Senior Software Engineer with a strong focus on web accessibility to lead our efforts in ensuring our public websites adhere to WCAG 2.1 guidelines. In this role, you will be driving initiatives to remediate accessibility issues and mentoring mid-level engineers to develop and maintain accessible digital experiences.

Key Responsibilities:

Lead and guide the remediation of accessibility issues on our public websites.

Mentor and guide mid-level engineers in best practices for web accessibility.

Update front-end codebases, including JSP, HTML, CSS, and STRUTS to ensure WCAG compliance.

Collaborate with cross-functional teams in an Agile workflow.

Identify and diagnose accessibility issues, recommending solutions to ensure optimal user experiences for all users.

Manage and track accessibility tasks and projects using tools like JIRA.

Requirements:

7+ years of experience in Software Engineering.

5+ years of hands-on experience in web accessibility remediation.

Profound knowledge of WCAG 2.1 guidelines and accessibility best practices.

Strong skills in Java/Spring, JSP, HTML, CSS, STRUTS. Familiarity with Angular and Bootstrap is a plus.

Experience working with JBOSS servers.

Familiarity with web accessibility testing tools.

Strong experience with issue and project tracking tools, preferably JIRA.

Knowledge and experience in Agile methodologies.

Preferred Qualifications:

Leadership experience with a proven track record of mentoring junior and mid-level engineers.

Certification in Web Accessibility (e.g., CPACC, WAS, or equivalent).

Experience or familiarity with Angular and Bootstrap.

Proactive, solution-oriented approach to problem-solving.

Recruiter Details:

Recruiter Name: Harry at gsksolutions dot com

Contact Number: Seven one nine-Two three nine-Five five five six

About GSK Solutions Inc:

GSK Solutions Inc is a leading information technology (IT) Services Company that specializes in providing complete consulting solutions and staff augmentation to its clients. We provide on-time, on-budget, and quality service to our clients and consistently meet their expectations. We are known for our superior execution on a sustained basis.

GSK has been in the business of providing both commercial and custom product development services, including, Information Security, Software Development, Consulting and IT Audit. GSK implements highly critical and time-sensitive projects for their Fortune 500 clients located across the country.

Expected salary: $65 per hour

Location: Denver, CO

Job date: Thu, 18 Jan 2024 23:19:45 GMT

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Job description: insights Work with Businesses and control functions in reviewing and challenging new product or service proposals for NPAC…The Cyber Risk Sr Group Mgr manages multiple teams through other managers. In-depth understanding of how own sub…

Expected salary:

Location: Canada

Job date: Fri, 05 Jan 2024 05:38:14 GMT

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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

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Job description: One of UK’s most prestigious law firms is seeking a Corporate Solicitor at a junior level circa 2ypqe to join its Cheltenham team.

The Team:

• Tier 1 ranked in the southwest
• Advise on high-profile UK and cross‑border mergers, acquisitions, and disposals (both public and private)
• IPOs
• AIM listings

Examples of work undertaken:

• Disclosure and due diligence processes
• Reviewing corporate and commercial documents, compiling relevant repots and identifying the key issues
• Liaising with and managing international legal counsel
• Corporate reorganisations and restructuring work
• Investment advisory mandates, negotiating shareholder agreements, share rights agreements, co-investment agreements
• Advise clients on general corporate issues, company law and company secretarial matters and the Takeover Code, Listing Rules and AIM Rules

Benefits:

• Hybrid working model
• Excellent career development
• Flexible leave
• Generous bonus scheme
• Life assurance
• Company pension scheme

This is an exciting opportunity for an ambitious corporate solicitor who is keen to further their career as the quality of work is second to none.

Please click the apply button to be considered for this role or please contact Loraine Silvester at G2 Legal if you would like to discuss further.

#G2JMS

Expected salary:

Location: Cheltenham, Gloucestershire

Job date: Thu, 21 Dec 2023 07:03:33 GMT

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Job description: We are looking for a trainee Retail Planner with some AutoCAD knowledge to join our growing team of talented planners, working with some of the biggest names in the .

The successful candidate will be working alongside knowledgeable and experienced as a critical member of the team. Using AutoCAD to update store plans in line with industry best practices. Internal training and mentoring by other planning personnel will also be provided.

Candidates must be UK-based, as our offices are located in Great Yarmouth. Options for fully remote working or a hybrid mix of office-based and home working.

Main duties:

• Undertaking store planning using AutoCAD, following clear briefs and examples supplied by our clients to deliver right first-time plans.
• Working to agreed time and quality constraints, promptly indicating issues requiring assistance or attention.
• Working in a positive manner with clients, supervisors, and other local or Great Yarmouth-based management and staff.
• Attending any designated client anywhere in the UK or overseas in some instances to support their in-house planning team.

Required skills:

• Competent in the use of AutoCAD.
• Well-versed in the use of Microsoft Office applications.
• An understanding of building, construction, shop fitting and refurbishment work would be beneficial, as would experience in a retail design and/or a planning environment.
• An interest in retail design.
• A full driving licence and willingness to travel.

Personal profile:

• Must enjoy working as part of a busy team.
• A positive mental attitude with a willingness to succeed.
• Enthusiastic and reliable.
• Good communication skills.

In return, CADS offers:

• The opportunity to join a thriving business, at an exciting time of growth

include, but not limited to, additional holiday purchase scheme, social events, flexitime, company healthcare cover (after a qualifying period) and a contributory pension scheme. * On-the-job training and progression opportunities

• Free car parking

Company values:

The successful applicant must also demonstrate an understanding and willingness to apply our workplace values which are

• Working with integrity
• Offering innovation
• Enjoying collaborations

All applicants will be asked to provide examples as part of their application and during the interview process. Interviews are expected to be held early in 2024, so if you are interested in this exciting opportunity, please submit your CV along with a covering letter detailing why you would be a great fit for this position.

Expected salary: £21880 per year

Location: Great Yarmouth, Norfolk

Job date: Sat, 25 Nov 2023 06:31:29 GMT

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Job description: At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department:

As a Programming Manager, you will be in the Statistical Programming team and Development Operations organization, responsible for supporting the development of new therapies by performing programming tasks and/or leading a small team to complete various programming efforts within a clinical trial. You will be responsible for ensuring integrity, consistency, and adherence to standards, and ensuring well-structured, high quality data summaries for internal decision making and reporting to health authorities. You will report to the Director, Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions as necessary.

Key responsibilities include:

• Supports and/or leads programming efforts within a clinical study, depending on background and experience.
• As a lead, reviews CRFs for adequacy and consistency.
• Supports the establishment and maintenance of Genmab SDTM and ADaM database standards.
• As a lead, co-develops analysis related derivation rules, develops data specifications for individual trials and provides guidance to internal programmers or vendors for doing the same.
• Performs database consistency checks on databases delivered by vendor.
• Performs sponsor oversight of programming activities performed by vendor.
• Supports in-house production of tables, figures, and listings by writing programming code following good programming practices.
• Supports in-house QC process by applying the appropriate measures (writing of code, review of code/deliverable).
• Supports submissions by ensuring programming deliverables are consistent with current agency standards and guidelines.
• Supports resource planning and outsourcing of programming activities.
• Supports developing and reviewing standard processes and templates.
• Supports process improvements within the programming department.
• Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge.
• Maintains up-to-date knowledge and competencies within relevant therapeutic and professional areas.
• Maintains up-to-date knowledge on relevant regulatory guidelines/requirements.
• Proactively develops and maintains good working relationship with stakeholders and colleagues.
• Participates and represents programming function in teams and meetings.
• Develops, maintains, and ensures proper documentation is available and properly stored (e.g., in eTMF) for programming activities.
• Supports development of GenSense Dashboards by providing guidance on data structure, organization, and contents of the Genmab SDTM-databases to the Dashboard- developers and programmers.

Requirements – what you must have

• Completed Bachelor of Science degree required or equivalent qualifications (e.g., programming experience and skills in the pharmaceutical industry).
• At least 3 years of direct experience in programming in the pharmaceutical industry.
• Knowledge, experience, and technical proficiency in the SAS software package.
• Experience working in a global context.
• Proficient in both written and spoken English.
• Oncology experience a plus.
• Programming in R or Python a plus.

As Programmer, it is expected that the employee:

• Acts as a role model
• Proactively engages in department activities
• Shares learnings with others
• Contributes to various initiatives within the department
• Proactively contributes to support a global organization

Required competences and skills:

• SAS programming
• Analytical and problem-solving skills
• Knowledge of the CDISC, SDTM and ADaM data models: the corresponding structures and organizations of the data
• Contextual understanding of the data
• Writes efficient, easily maintained and well documented computer programs
• Is systematic and organized in writing and archiving computer programs as well as other documentation
• Thorough
• Proactive, accountable, and goal oriented
• Innovative
• Team player
• Good at sharing knowledge
• Takes responsibility and shows initiative
• Good communication skills
• Good planning and coordination skills
• Ability to flexibly work on multiple tasks without compromise of the quality of the work

Where you will work

This role is strongly preferred to be based in Princeton, NJ USA, or Copenhagen, Denmark and is hybrid (according to Genmab’s onsite and work-from-home flexibility).

Candidates who must be remote (not within commuting distance to Genmab offices) could be considered.

For US based candidates, the proposed salary band for this position is as follows:

$95,625.00—$159,375.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other – rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on .

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website .

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Expected salary:

Location: Princeton, NJ

Job date: Wed, 03 Jan 2024 06:47:15 GMT

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Job description: ABOUT US SAP Fioneer builds software and platforms that enable banks, insurance companies and challengers to run, transform and grow – cost-efficiently and at scale and speed. Backed by global technology leader SAP and entrepreneurial i…

Expected salary:

Location: Toronto, ON

Job date: Fri, 29 Sep 2023 22:17:38 GMT

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Job description: + Excellent Benefits UK wide / Hybrid Working UK wide hybrid working lean consulting opportunities created due… to organisation growth Global market-leading management consultancy Strong lean and continuous improvement skills from any sector…

Expected salary: £60000 – 75000 per year

Location: United Kingdom

Job date: Fri, 22 Dec 2023 05:53:34 GMT

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Job description: Work Location – Hybrid, (must be located in the United States) Summary The Strategic Planning Sr. Advisor is a new… Group has a tobacco-free policy and reserves the right not to hire tobacco/nicotine users in states where that is legally…

Expected salary: $109300 – 182100 per year

Location: Birmingham, AL

Job date: Fri, 29 Dec 2023 23:50:23 GMT

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