Director of Statistical Programming: Strategic CRO Leader

Skyhawk Therapeutics; Waltham (MA); On-site; USD 225,000 - 325,000; Full time

Job summary

Skyhawk Therapeutics in the United States is seeking a Director/Senior Director of Statistical Programming to lead and scale the programming function. You will set strategic direction, oversee CRO partnerships, and drive high-quality delivery across the clinical portfolio, reporting to the Executive Director of Biostatistics.

This role requires 10+ years of SAS programming experience, strong SDTM/ADaM, and proven leadership.

Qualifications

• 10+ years of statistical programming experience in CRO/biopharma.
• Expert SAS programming skills (BASE/SAS, SAS/STAT, SAS/GRAPH, SAS MACROS).
• Strong SDTM/ADaM experience.
• Regulatory submission support experience.
• Proven leadership and collaboration abilities.

Responsibilities

• Define and evolve outsourcing strategy; oversee CRO programming.
• Lead cross-functional teams to inform strategic decisions.
• Direct programming portfolio and standards across programs.
• Develop and govern programming standards per regulatory guidelines.
• Oversee CRO delivery of analysis datasets, listings, tables, figures; ensure quality and milestones.
• Mentor and develop statistical programming talent.
• Collaborate with regulatory affairs for submissions.

Skills

SAS programming

CDISC SDTM/ADaM

GCP/ICH guidelines

CRO relationship management

Team leadership

Tools

SAS suite

Job description

Skyhawk Therapeutics in the United States is seeking a Director/Senior Director of Statistical Programming to lead and scale the programming function. You will set strategic direction, oversee CRO partnerships, and drive high-quality delivery across the clinical portfolio, reporting to the Executive Director of Biostatistics.

This role requires 10+ years of SAS programming experience, strong SDTM/ADaM, and proven leadership.