Director / Senior Director of Statistical Programming

Skyhawk Therapeutics•Waltham, MA

About The Position

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.

Requirements

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

Responsibilities

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