Associate Director, Statistical Programming

Verastem•Needham, MA

9h•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 supports the generation of tables, figures, and listings for clinical study reports, FDA submissions, and medical congress abstracts/posters/presentations. The position is responsible for internal statistical programming deliveries across multiple clinical studies, implementing process improvements, and driving department initiatives. The role involves identifying areas within clinical development functions where statistical programming tools can enhance processes, performing quality control checks of SAS code and output, and collaborating with clinical operations, data management, and statisticians to develop infrastructure for timely and quality reporting of clinical trials. The Associate Director will proactively identify issues and recommend solutions to optimize preparation, execution, reporting, and documentation of statistical programming activities, provide project management and technical guidance, and liaise with vendors for electronic data transfers and statistical 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.
OR 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.
If qualifying with bachelor’s degree, must have: 9 years of experience with SAS programming.
9 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
7 years of experience with CDISC SDTM and ADaM.
7 years of experience with electronic FDA submission.
9 years of experience working in a clinical trial setting.
If qualifying with Master’s degree, must have: 7 years of experience with SAS programming.
7 years of experience using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
5 years of experience with CDISC SDTM and ADaM.
5 years of experience with electronic FDA submission.
7 years of experience working in a clinical trial setting.
Unrestricted authorization to work in the United States.

Responsibilities

Lead design and development of SAS programs and programming specifications for producing and validating CDISC ADaM datasets.
Support the generation of tables, figures, and listings for clinical study reports, FDA submissions, and medical congress abstracts/posters/presentations.
Oversee internal statistical programming deliveries across multiple clinical studies.
Implement 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.
Collaborate with clinical operations, data management, and statisticians to develop infrastructure for timely and quality reporting of clinical trials.
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.