Associate Director, Statistical Programming

Verastem • Needham, MA

2d • $164,950 - $190,000 • Hybrid

About The Position

The Associate Director, Statistical Programming will lead the design and development of SAS programs and programming specifications for producing and validating CDISC ADaM datasets. This role is responsible for supporting the generation of tables, figures, and listings for clinical study reports, FDA submissions, and medical congress abstracts/posters/presentations. The position involves overseeing internal statistical programming deliveries across multiple clinical studies, implementing process improvements, and identifying areas within clinical development where statistical programming tools can enhance processes. The role also includes performing quality control checks of SAS code and output, collaborating with clinical operations, data management, and statisticians to develop infrastructure for timely and quality reporting, proactively identifying and resolving issues, providing project management and technical guidance, and liaising with vendors for data transfers and programming support.

Requirements

• Bachelor’s or equivalent in Regulatory Affairs, Statistics, Computer Science or related field plus nine years of work experience in clinical data and statistical programming in pharmaceutical or biotech industries
• Master’s degree or equivalent in Regulatory Affairs, Statistics, Computer Science or related field plus seven years of work experience in clinical data and statistical programming in pharmaceutical or biotech industries
• 9 years of experience with SAS programing (if qualifying with bachelor's degree)
• 9 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS (if qualifying with bachelor's degree)
• 7 years of experience with CDISC SDTM and ADaM (if qualifying with bachelor's degree)
• 7 years of experience with electronic FDA submission (if qualifying with bachelor's degree)
• 9 years of experience working in a clinical trial setting (if qualifying with bachelor's degree)
• 7 years of experience with SAS programing (if qualifying with Master's degree)
• 7 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS (if qualifying with Master's degree)
• 5 years of experience with CDISC SDTM and ADaM (if qualifying with Master's degree)
• 5 years of experience with electronic FDA submission (if qualifying with Master's degree)
• 7 years of experience working in a clinical trial setting (if qualifying with Master's degree)
• Unrestricted authorization to work in the United States

Responsibilities

• Lead design and development SAS programs and the programming specifications for producing and validating CDISC ADaM datasets to support the generation of tables, figures and listings for clinical study report(s), FDA submission(s), and medical congress abstracts/posters/presentations
• Responsible for internal statistical programming deliveries across multiple clinical studies, as well as implementing process improvements and department initiatives
• Identify areas within clinical development functions where statistical programming tools and applications can enhance processes
• Perform quality control checks of advanced SAS code and output produced by other statistical programmers
• Work closely with clinical operations, data management and statisticians to develop infrastructure for timely and quality reporting of clinical trials to support regulatory requirements, and product launch activities
• Proactively identify issues and recommend solutions to optimize preparation, execution, reporting, and documentation of statistical programming activities
• Provide project management and technical guidance to ensure operational and technical excellence
• Liaise with vendors as needed to facilitate electronic data transfers and statistical programming support

What This Job Offers

• Job Type: Full-time
• Career Level: Manager