Associate Director, Statistical Programming

Kardigan•Princeton, NJ

6d•$183,000 - $250,000•Onsite

About The Position

The Associate Director of Statistical Programming serves as the compound lead, responsible for programming strategy and delivery across all studies and integrated analyses for an assigned compound. The role leads internal and outsourced programming activities, ensuring quality, consistency, and timely delivery of clinical reporting and regulatory submission deliverables while remaining hands-on in SAS and R programming and technical review. As the primary Statistical Programming representative on compound teams, this position partners with Biostatistics and Clinical Data Management to align data collection, analysis requirements, and programming plans. The compound lead establishes consistent programming standards across studies, coordinates resources and timelines, and proactively addresses delivery risks. The role also contributes to SOPs and programming standards and the modernization of statistical reporting with open-source tools. The position is within Clinical Data Sciences & Analytics and reports to the Head of Statistical Programming. It is based in South San Francisco, California, or Princeton, New Jersey, and is on-site four days per week, Monday through Thursday.

Requirements

Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
Advanced SAS and R programming skills and experience using Git for version control.
Extensive hands-on experience with SDTM, ADaM, and TLF programming.
In-depth knowledge of CDISC standards (SDTM and ADaM) and regulatory submission requirements, with hands-on experience applying the standards and leading programming deliverables for regulatory submissions.
Strong knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology, and the ability to translate analysis plans into programming requirements.
Excellent communication and collaboration skills, including the ability to represent Statistical Programming on cross-functional compound teams, influence decisions, and communicate technical risks and recommendations clearly.
Practical experience with data validation, define.xml generation, and tools such as Pinnacle 21, including preparing and reviewing supporting reviewer guides and resolving or documenting conformance findings.
Experience managing outsourced programming activities and overseeing CROs and contractors, including defining scope and quality expectations, monitoring timelines and budgets, and resolving delivery issues.
Demonstrated ability to provide technical leadership and mentoring to study programmers and lead a programming team while remaining hands-on in programming and technical review.

Nice To Haves

Eight or more years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment, including demonstrated experience leading programming across multiple studies within a compound or development program.
Broad expertise in statistical programming and developing compound-level programming strategies, including cross-study standards, resource planning, timeline management, and risk mitigation.
Experience with regulatory audits and inspections, such as FDA, PMDA, NMPA, or EMA.

Responsibilities

Serve as compound programming lead, accountable for study- and compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams.
Develop and maintain programming plans, coordinate timelines and resource needs across studies, address delivery risks, and escalate resource constraints and unresolved issues to the Head of Statistical Programming.
Lead programming review of SAPs, Data Presentation Plans, and Table Shells across the compound to align with development objectives and ensure programming assumptions and requirements are clear, consistent, and complete.
Lead production and/or validation of SDTM, ADaM, and TLF deliverables across studies and integrated analyses for clinical study reports, regulatory requests, publications, and ad hoc analyses; perform complex programming and technical review as needed.
Manage CROs and contractors supporting the compound by defining scope and acceptance criteria and ensuring compliance, quality, and timely delivery.
Collaborate with biostatisticians and clinical development colleagues to develop and review TLF shells, SDTM and ADaM specifications, and consistent data standards and derivation conventions across studies.
Work with Data Management and Biostatistics to ensure database-lock readiness and the accuracy and traceability of final datasets, analyses, and reports across the compound.
Develop company tools, including R packages, macros, and interactive data dashboards such as Shiny applications, to improve Statistical Programming team efficiency and capacity.
Oversee development and validation of define.xml and supporting reviewer guides.
Lead preparation of compound programming deliverables for NDA eSubmissions, including integrated analyses, and coordinate programming support for regulatory question responses.
Partner with the Head of Statistical Programming to lead initiatives implementing innovative strategies and technologies and drive their adoption across compound studies.
Contribute to departmental Statistical Programming standards and SOPs, and lead implementation of programming strategies, specifications, and standardized analyses across studies within the assigned compound.
Identify gaps and risks in programming capabilities and processes, lead improvement plans, and share lessons learned and best practices across the Statistical Programming team.
Provide technical leadership and mentoring to study programmers while leading the programming team and remaining hands-on in programming and technical review.