Head of Statistical Programming — Biotech Impact

Damora Therapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Damora Therapeutics, Inc. in Boston, MA seeks a Head of Statistical Programming to lead the programming function across its clinical portfolio. You will define strategy, manage internal staff and CROs, and ensure regulatory-ready programming deliverables.

The role requires extensive experience in SAS/R, CDISC, and ICH-GCP, with a track record of leading programming through NDA/BLA submissions and working cross-functionally with Biostatistics and Regulatory Affairs.

Qualifications

• Requires Bachelor’s degree in computer science, statistics, mathematics, data science, or analytics with 12+ years in biotech/pharma/CRO; or Master’s with 10+ years.
• Progressive leadership in statistical programming; experience leading a programming function or large team.
• Experience directing programming deliverables for regulatory submissions and working with CROs/vendors.
• Hands-on proficiency in SAS and R; familiarity with automation and open-source approaches.
• Strong knowledge of CDISC data standards and regulatory guidelines (ICH-GCP).
• Excellent communication skills and ability to influence at multiple levels.

Responsibilities

• Set vision and operating model for statistical programming across Damora clinical programs.
• Ensure on-time completion of programming deliverables with quality and compliance.
• Lead CRO/vendor programming teams and oversee external partnerships.
• Provide regulatory submission and inspection readiness input for programming deliverables.
• Manage resources, risk, and budget to meet business needs.
• Develop and mentor a high-performing programming team.

Skills

Leadership

SAS

R

CDISC

ICH-GCP

Regulatory submissions

Vendor management

Communication

Programming strategy

Education

Bachelor's degree in CS/Stats

Master's degree in related field

Tools

SAS

R

CDISC standards

Job description

Damora Therapeutics, Inc. in Boston, MA seeks a Head of Statistical Programming to lead the programming function across its clinical portfolio. You will define strategy, manage internal staff and CROs, and ensure regulatory-ready programming deliverables.

The role requires extensive experience in SAS/R, CDISC, and ICH-GCP, with a track record of leading programming through NDA/BLA submissions and working cross-functionally with Biostatistics and Regulatory Affairs.