Associate Director, Statistical Programming

• →Oversee the development and validation of SAS programs to generate datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in compliance with CDISC standards.
• →Ensure the timely and high-quality delivery of programming outputs for regulatory submissions, clinical study reports, and exploratory analyses.
• →Ensure all programming activities align with industry standards (CDISC, ICH, FDA, EMA) and internal SOPs.
• →Programming lead for clinical programs as needed. Hand-on programming work in SAS and other programming languages/tools.
• →Establishes and maintains CRO/vendor partnerships.
• →Act as a liaison between statistical programming and other functions, ensuring clear communication and alignment of goals.
• →Partner with biostatistics, data management, and clinical operations to resolve programming issues and optimize processes.
• →Identify and implement new tools, techniques, and processes to improve efficiency and quality in statistical programming.

• Master’s degree in statistics, computer science or a related field
• At least 8 years of statistical programming experience in the pharmaceutical/biotech industry
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Extensive experience in leading statistical programming function for both early and late phase clinical trials, and regulatory submissions (NDA/BLA, MAA)
• Excellent skills in SAS programming and statistical reporting, knowledge of R and R Shiny desirable
• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
• Familiarity with FDA and ICH regulations and guidelines
• Excellent written and verbal communication skills, ability to collaborate with a multidisciplinary team and interact effectively in a fast-paced team environment

Location: This is a hybrid role with three days per week in-office in Burlington, Massachusetts.