Director / Senior Director of Statistical ProgrammingThis role is responsible for setting the strategic direction of programming operations, overseeing CRO partnerships, and driving high-quality delivery across the clinical portfolio. Reporting to the Executive Director of Biostatistics, this role serves as a key technical and operational leader, shaping programming standards, cross-functional collaboration, and the development of internal capabilities.
Responsibilities (including, but not limited to):- Define and evolve the statistical programming outsourcing strategy; provide executive oversight of all programming activities outsourced to CRO
- Lead and partner with cross-functional teams (Biostatistics, Clinical Operations, Regulatory, Data Management) to direct internal exploratory analyses and inform strategic decisions
- Lead the statistical programming portfolio across multiple programs; define and implement department-wide programming strategies and standards
- Champion the development, implementation, and governance of programming standards and specifications in accordance with regulatory guidelines; ensure consistency across the clinical portfolio
- Provide strategic oversight of CRO programming delivery, including analysis datasets, listings, tables, and figures for clinical trials; ensure adherence to specifications, quality standards, and milestones; contribute hands-on programming expertise as the business requires for clinical trials with high quality and within milestones
- Provide senior-level input into SAPs, CRFs, and data structures; ensure all documents and specifications maintain cross-functional consistency and compliance with regulatory structures
- Establish and oversee processes for documentation, record-keeping, and archiving of all project analyses and associated documentation; build scalable processes to support growing clinical programs
- Recruit, mentor, and develop statistical programming talent; build a high-performing team culture centered on scientific rigor, innovation, and continuous improvement
- Serve as the internal expert and point of escalation for complex programming issues; collaborate with Regulatory Affairs on agency submissions and responses
- Evaluate, select, and manage programming tools, technologies, and vendors to support an efficient and scalable programming infrastructure
Requirements, Education, Experience & Skills:- 10+ years of statistical programming experience in the CRO or biopharmaceutical industry
- Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
- Strong CDISC SDTM and ADaM experience
- Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Experiece supporting regulatory submissions (e.g., NDA. BLA, or MAA)
- Strong initiative and a collaborative team player; ability to work with a variety of both internal and external stakeholders
- Excellent attention to detail and problem-solving skills with a demonstrated ability to identify data and programming gaps and drive them to resolution
- Demonstrated experience managing CRO relationships and leading vendor oversight programs at a strategic level
- Excellent written and oral communication skills; ability to effectively communicate complex technical concepts to senior leadership and non-technical stakeholders
- Proven ability to work strategically and independently; comfortable operating in a fast-paced, dynamic environment with competing priorities
- Experience with people management, team development, or mentoring statistical programming staff
Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Director / Senior Director of Statistical Programming role is $225,000-325,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.
