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<b>Job title:</b> (Senior) Manager* Statistical Programming &#8211; REMOTE<br />
<br /><b>Company:</b> Proclinical</p>
<p><b>Job description</b>: Salary: Highly Competitive Salary<br />
 </p>
<ul>
<li>Job type:</li>
</ul>
<p> Permanent * Discipline:<br />
 <br /> Statistics, Informatics, Programming * Location:<br />
 <br /> United States</p>
<p> Alamogordo, USA</p>
<p> Posting date: 15 Nov 2023</p>
<p> Reference: SS.MH.57592</p>
<p> Proclinical is seeking a remote (Senior) Manager* Statistical Programming for a cutting-edge biotech company.</p>
<p> Must be eligible to work in the US.</p>
<p> <b>Job Responsibilities:</b> </p>
<ul>
<li>Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting</li>
<li>Independently perform or oversee the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries</li>
<li>Anticipate resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project</li>
<li>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</li>
<li>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</li>
<li>Provide functional expertise in the development and implementation of centralized clinical data repository, clinical data dictionary, and operational data dictionary</li>
<li>Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools</li>
<li>Provide programming support to the regulatory submissions including data submission package and define.xml development</li>
</ul>
<p> <b>Skills and Requirements:</b> </p>
<ul>
<li>BSc in Statistics, Mathematics, Computer Science, or related discipline, advanced degree preferred</li>
<li>5+ years (3+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting</li>
<li>Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.</li>
<li>Good understanding of FDA, EMA, ICH, and global regulations and guidelines</li>
<li>Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards</li>
<li>Oncology or Infectious Disease therapeutic areas and submission experience is preferred</li>
<li>Project management experience, detail-oriented, and strong organizational and communication skills in English (written and Spoken)</li>
<li>Ability to work in a fast-paced, dynamic team environment as well as strong analytical and problem solving skills</li>
</ul>
<p> 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.</p>
<p> Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.</p>
<p> Proclinical Staffing is an equal opportunity employer.</p>
<p> #LI-MH2<br />
<br /><b>Expected salary</b>:<br />
<br /><b>Location</b>: USA<br />
<br /><b>Job date</b>: Fri, 17 Nov 2023 05:47:06 GMT</p>
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