Associate Director, Statistical Programming

What You’ll Do: Reporting to the Senior Director, Statistical Programming, the Associate Director will provide statistical and clinical data programming expertise to manage statistical programming activities that support drug development programs and regulatory submissions. This role involves overseeing the creation, validation, and delivery of programming deliverables, ensuring compliance with industry standards, and fostering cross-functional collaboration with biostatistics, data management, clinical, and regulatory teams.  

Responsibilities: 

• 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.

Qualifications:

• 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.