Penfield Search Partners
Contact: Linda Aronova 646.882.9021 firstname.lastname@example.org
- 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.