Lead Statistical Programmer

Job Description :

The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas. The role oversees external CRO partners to ensure high-quality, timely, and compliant delivery of analysis datasets, tables, listings, and figures that support clinical development and regulatory submissions. The position involves hands-on technical leadership and requires comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and the drug development process.

Responsibilities :

• Lead statistical programming activities and deliverables (, SDTM / ADaM datasets, tables, listings, figures, review esub data packages with Pinnacle ) across multiple studies and programs, serving as the primary programming point of contact. Must be able to review TMF for programming deliverables, including SAP.
• Oversee CRO programming activities by reviewing programming plans, SDTM / ADaM specifications, TLF shells, validation strategies, and issue logs.
• Monitor internal and CRO delivery against timelines, quality metrics, and contractual obligations; identify risks and implement mitigation or corrective actions as needed.
• Ensure consistency of standards, templates, macros, and processes across internal and external teams, and drive adoption of programming best practices.
• Provide hands-on programming support to complex or high-priority analyses, ad-hoc requests, and regulatory responses, as needed.
• Partner with biostatistics to design, implement, and maintain programming development plans for each project, ensuring timely and high-quality deliverables aligned with internal and industry standards.
• Partner with data management to apply CDISC standards during CRF design and database development.
• Partner with biostatistics, data management, clinical, regulatory, pharmacovigilance, and project management to align programming strategies with study-level plans and regulatory expectations.
• Collaborate with medical writing, clinical, and regulatory on study-level initiatives.
• Support inspection and audit readiness by ensuring appropriate documentation, traceability, and reproducibility of programming deliverables from both internal and CRO teams.

Minimum Education, Certifications, Licenses, and Experience :