Senior Manager, Statistical Programming

Position Title: Senior Manager, Statistical Programming

Department: Clinical Data Sciences & Analytics 

Reports To: Head of Statistical Programming

Location: South San Francisco, CA or Princeton, NJ – On-site 4 days per week (Mon to Thurs) 

Job Overview:

The Senior Manager of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks.

This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this position will play an important role in establishing SOPs and programming standards and modernizing statistical reporting with open-source tools.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Key Project Responsibilities:

• Provide programming leadership and oversee study to compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams.
• Serve as the lead programmer to review the SAP, Data Presentation Plan, and Table Shells to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
• Lead programming team to produce and/or validate SDTM, ADaM, and TLF for CSR and regulatory requests, publication needs, and ad-hoc analyses.
• Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
• Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
• Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team.
• Develop robust programs to create define.xml. Lead the NDA eSubmission package preparation.
•  

Initiative Responsibilities:

• Under the guidance of the Head of Statistical Programming and Compound Lead, implement innovative strategies and technologies to enhance programming processes.
• Working with the manager, establish Statistical Programming standards and deploy programming strategies, specifications, and programmed analyses.
• Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability.

Qualifications and Preferred Skil