Associate Director SAS Programmer

  • Anywhere

Company :
Adaptimmune Ltd

Location :
Philadelphia, Pennsylvania

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
The Associate Director SAS Programmer will be the Lead Statistical Programmer on multiple complex projects or products in the Statistical Programming function, including NDA/BLA and other submissions to regulatory agencies. Lead, manage, coach, develop, and support Statistical Programmers within the Biostatistics Department Author or provide input to key study-related documents produced by other functions (e.g. Statistical Programming Plan, SAP, CRFs, Data Management Plan, etc.) Ensure the quality of Statistical Programming deliverables, including oversight of CRO biostatistics deliverables Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit Perform/assess time and resource estimates for project planning, managing timelines for studies/projects Provides technical guidance to statistical programmers and vendors around project conventions, standards, practices, and specifications to ensure integrated computing solutions Qualifications & Experience BS or MS in Statistics, Biostatistics, Computer Science, or related analytical field 10 + years (MS) or 12 + years (BS) SAS programming experience in the pharmaceutical/CRO industry with support of clinical trials across all phases of development including NDA/EMEA/CTD submissions 6+ years of CRO/Vendor management experiences In-depth knowledge of statistical programming languages (including SAS), software, techniques, and products related to statistical programming, databases and computing environments. Strong knowledge of SAS software products related to the pharmaceutical industry, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office) Solid understanding of FDA, EMA, ICH and other regional and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions, eg. CDISC standards Expertise in the requirements and technology required to support electronic submissions. At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.