Associate Director, Statistical Programming
Zenas BioPharma
August 20, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary
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. The role includes strategic contributions to departmental infrastructure (process optimization and tool development) and involves direct management and oversight of internal, contract, and FSP programming resources.
Key Responsibilities
- Act as the primary statistical programming contact and knowledge expert for assigned protocols, studies, and integrated analyses.
- Oversee statistical programming activities (internal staff, CROs, FSP). Ensure quality, timelines, and scope alignment.
- Collaborate cross-functionally (Biostatistics, Data Management, Clinical Operations) for expert programming support.
- Lead/contribute to departmental process improvement, standardization, and development/implementation of programming tools and macros.
- Review and provide expert input on SDTM/ADaM specifications, datasets, define.xml, reviewer guides, and validation reports.
- Perform QC of SDTM/ADaM datasets and TFLs.
- Program TFLs for ad hoc analyses, posters, publications, and regulatory interactions.
- Review clinical protocols, SAPs, and mock TFL shells.
- Mentor/line-manage junior programmers and assigned contract/FSP resources.
- Manage relationships and performance with contract programming resources and FSP.
Qualifications
- Master’s in Biostatistics, Computer Science, or related field with 7+ years CRO/biotech/pharma clinical trials experience (all phases), or Bachelor’s with 9+ years relevant experience.
- CRO/vendor management experience.
- NDA/BLA and regulatory filing experience.
- Experience with ISS/ISE.
- Strong CDISC (SDTM/ADaM) knowledge; strong SAS programming skills.
- Knowledge of ICH, FDA, EMA, and NMPA regulations/guidelines.
- Excellent interpersonal and problem-solving skills; strong oral/written communication.
- Cross-functional experience; R experience preferred.
- Able to work in fast-paced start-up environment with evolving processes; flexible with non-traditional hours.
Benefits/Compensation
- Competitive compensation and benefits package; base salary range: $171,500 to $214,423.
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. The role includes strategic contributions to departmental infrastructure (process optimization and tool development) and involves direct management and oversight of internal, contract, and FSP programming resources.
Key Responsibilities
- Act as the primary statistical programming contact and knowledge expert for assigned protocols, studies, and integrated analyses.
- Oversee statistical programming activities (internal staff, CROs, FSP). Ensure quality, timelines, and scope alignment.
- Collaborate cross-functionally (Biostatistics, Data Management, Clinical Operations) for expert programming support.
- Lead/contribute to departmental process improvement, standardization, and development/implementation of programming tools and macros.
- Review and provide expert input on SDTM/ADaM specifications, datasets, define.xml, reviewer guides, and validation reports.
- Perform QC of SDTM/ADaM datasets and TFLs.
- Program TFLs for ad hoc analyses, posters, publications, and regulatory interactions.
- Review clinical protocols, SAPs, and mock TFL shells.
- Mentor/line-manage junior programmers and assigned contract/FSP resources.
- Manage relationships and performance with contract programming resources and FSP.
Qualifications
- Master’s in Biostatistics, Computer Science, or related field with 7+ years CRO/biotech/pharma clinical trials experience (all phases), or Bachelor’s with 9+ years relevant experience.
- CRO/vendor management experience.
- NDA/BLA and regulatory filing experience.
- Experience with ISS/ISE.
- Strong CDISC (SDTM/ADaM) knowledge; strong SAS programming skills.
- Knowledge of ICH, FDA, EMA, and NMPA regulations/guidelines.
- Excellent interpersonal and problem-solving skills; strong oral/written communication.
- Cross-functional experience; R experience preferred.
- Able to work in fast-paced start-up environment with evolving processes; flexible with non-traditional hours.
Benefits/Compensation
- Competitive compensation and benefits package; base salary range: $171,500 to $214,423.