Associate Director, Statistical Programming

Kardigan•Princeton, CA

5d•$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 role establishes consistent programming standards across studies, coordinates resources and timelines, and proactively addresses delivery risks. It also contributes to developing SOPs and programming standards and modernizing statistical reporting with open-source tools. The position is in the Clinical Data Sciences & Analytics department and is based in South San Francisco, California, or Princeton, New Jersey. It 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, with 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 clearly communicate technical risks and recommendations.
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 a 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 the 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 clear, consistent, and complete programming assumptions and requirements.
Lead the programming team in producing and/or validating SDTM, ADaM, and TLF deliverables across studies and integrated analyses for CSRs, regulatory requests, publications, and ad hoc analyses; remain hands-on for complex programming and technical review.
Manage CROs and contractors supporting the compound by defining scope and acceptance criteria and ensuring compliance, deliverable quality, and timely completion.
Collaborate with biostatisticians and clinical development colleagues to develop or 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, such as R packages, macros, and interactive data dashboards, to improve the efficiency and capacity of the Statistical Programming team.
Oversee development and validation of define.xml and supporting reviewer guides.
Lead preparation of the compound’s programming deliverables for NDA eSubmissions, including integrated analyses, and coordinate programming support for responses to regulatory questions.
Partner with the Head of Statistical Programming to lead initiatives implementing innovative strategies and technologies that enhance programming processes and drive 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.