Our client is a biotech company focused on developing breakthrough therapies in Oncology. The Associate Director, Statistical Programming will be responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical trial results. This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance. The ideal candidate will have a strong background in oncology and substantial experience in Statistical Programming within the biotech or pharmaceutical industry. This job will be hybrid on-site in the client's San Francisco Bay Area office.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Develop specifications, build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc and regulatory review
- Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses
- Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications
- Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and and output displays
- Validate data and results of statistical analyses generated by CROs
- Manage internal programming resources for study deliverables as applicable
- Review Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study report
- Manage on-time and quality delivery of CRO-generated analyses results
- Stay current with regulatory requirements on CDISC and clinical regulatory programming standards
- Works with line manager and/or Head of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
- Utilize CDISC implementation guides and industry validation software to check compliance of CDISC data packages (SEND, SDTM, and ADaM, define.xmls and reviewer's guides)
- Evaluate CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness as applicable
- Participate in standards governance and developing biometric department operational processes as applicable
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred)
- 10+ years of experience in clinical trial development (late stage preferred)
- FDA/EMEA submission experience a plus
- Demonstrated ability for project management of statistical programming projects in clinical development
- Experience managing delivery of statistical programming projects by CROs
- Ability to navigate uncertainty with creative problem solving and take a hands-on, "roll up your sleeves" approach
- Strong knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
- Strong knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
- Depth of knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer's guides (SDRG, ADRG)
- Experience with clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferred
- Familiarity with data visualization tools (e.g Spotfire, Tableau, RShiny) a plus
- Ability to operate independently in unstructured situations
- Ability to communicate technical information to a non-technical audience