Associate Director, Statistical Programming

Role Summary

Reporting to the Head of Statistical Programming, the Associate Director is 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, and enhancements of the statistical programming infrastructure of the Biometrics department as applicable.

Responsibilities

• Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications
• Review Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study report
• 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
• Manage on-time and quality delivery of CRO-generated analyses results
• Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and output displays
• Validate data and results of statistical analyses generated by CROs
• Manage internal programming resources for study deliverables as applicable
• Stay current with regulatory requirements on CDISC and clinical regulatory programming standards
• Utilize CDISC implementation guides and industry validation software to check compliance of CDISC data packages (SEND, SDTM, and ADaM, define.xmls and reviewer‚Äôs 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
• 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

Qualifications

• In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
• In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
• In-depth knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer‚Äôs guides (SDRG, ADRG)
• Knowledge of 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

Education

• 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, ‚Äúroll up your sleeves‚Äù approach