Manager/Sr Manager of Statistical Programming

Key Responsibilities

• Lead statistical programming activities for multiple clinical trials within a program or complete development program
• Ensure timely and quality development and validation of all statistical programming components; maintain audit readiness and accuracy of statistical analysis results
• Serve as lead programmer to produce/validate tables, listings, figures, and analysis datasets for regulatory requests, publications, and ad-hoc analyses; write specifications for programming requirements
• Oversee CRO SAS programming by reviewing activities and progress to ensure timely, high-quality delivery
• Collaborate with Data Management and Biostatistics teams to ensure accuracy of final databases, analyses, and reports; manage study-level programming timelines with biostatisticians and cross-functional teams
• Develop/review TFL shells, SDTM, and ADaM specifications with biostatisticians and clinical development colleagues
• Identify issues and create global tools (e.g., macros or GUI applications) to enhance efficiency and capacity of the statistical programming group
• Maintain advanced knowledge of SAS software, industry standards (CDISC, eCTD, Define.xml), and attend functional meetings/training
• Represent statistical programming in program-level audits, inspections, and Health Authority meetings
• Provide expert technical recommendations and thought leadership for statistical programming at the program level
• Adhere to FDA regulations, company SOPs/WIs, and department guidelines

Qualifications

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent; 5+ years in programming or statistical roles
• 2+ years as a Lead/Program/Project Programmer, coordinating large teams of internal/external programmers
• Demonstrated leadership, collaboration, and organizational skills to manage multiple trials simultaneously and meet deadlines
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
• Advanced knowledge of CDISC standards and standard program development
• SAS programming skills: Macro language, BASE SAS, SAS/STAT, SAS/GRAPH, validation/QC, generating listings, tables, figures
• R programming experience is a plus
• Ability to program defensively, check results, and produce accurate outputs consistently
• Knowledge of regulatory guidelines (FDA, EMA, ICH) for clinical trials, statistics, and data handling; advanced understanding of submission requirements
• Experience reviewing statistical analysis plans and developing technical programming specifications
• Experience outsourcing programming activities and overseeing CRO/contractor services
• NDA submission experience is a plus
• Excellent interpersonal skills for global collaboration and communication across functions and external stakeholders
• Ability to thrive in evolving situations, embrace organizational changes, and manage multiple responsibilities under pressure