Associate Director, Statistical Programming

Zenas BioPharma•Waltham, MA

5d•Hybrid

About The Position

The Associate Director, Statistical Programming will independently lead and execute programming activities aligned with project strategies to support clinical studies, study reports, and regulatory submissions. This role extends beyond study support to include strategic contributions to departmental infrastructure, such as process optimization and tool development. The position also involves direct management and oversight of internal, contract, and FSP programming resources.

Requirements

Master’s degree in Biostatistics, Computer Science or related discipline, 7+ years’ experience working across all phases of clinical trials in CRO/Biotech/ Pharmaceutical company; or Bachelor’s degree with 9+ years of relevant experience.
Experience managing CROs and vendors.
NDA/BLA and other regulatory filing experience.
Experience with ISS/ISE.
Strong knowledge of CDISC standards for SDTM and ADaM.
Strong knowledge of ICH, FDA, EMA, and NMPA regulations and guidelines.
Exceptional interpersonal skills and problem-solving capabilities.
Excellent oral and written communication skills.
Experience working with cross-functional teams.
Excellent SAS programming skills.
Comfortable working in a demanding, fast-paced, start-up culture with evolving processes.
Flexible and able to adapt to new situations as the business demands.
Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.

Nice To Haves

Experience with other statistical software tools (e.g., R) preferred.

Responsibilities

Act as the primary statistical programming contact and knowledge expert for assigned protocols, studies, and integrated analyses.
Provide oversight of statistical programming activities, including those of internal staff, CROs, and FSP teams.
Ensure deliverables meet quality standards, study timelines, and agreed scope.
Collaborate across functions (e.g., Biostatistics, Data Management, Clinical Operations) to provide expert programming support and strategic input.
Lead or contribute to departmental initiatives for process improvement, standardization, and the development or implementation of programming tools and macros to enhance efficiency and quality.
Review and provide expert input on SDTM and ADaM specifications, datasets, define.xml, reviewers guides, and validation reports.
Perform QC of SDTM datasets, ADaM datasets, and Tables, Figures, and Listings (TFLs).
Program TFLs for ad hoc analyses, posters, publications, and regulatory interactions.
Participate in the review of clinical study protocols, statistical analysis plans, and mock TFL shells.
Mentor, guide, and provide line management to junior programmers and assigned contract/FSP resources.
Manage relationships and performance with contract programming resources and Functional Service Providers (FSP).