Director / Senior Director of Statistical Programming
Skyhawk Therapeutics is seeking an experienced and strategic Director / Senior Director of Statistical Programming to lead and scale the statistical programming function. This 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 $225,000-315,000 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.
About Skyhawk
Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.
