Director of Statistical Programming

PRIMARY RESPONSIBILITIES

• Team Leadership: Build, mentor, and direct a high-performing statistical programming team, fostering technical excellence and overseeing their professional development.
• Functional Oversight: Provide strategic direction and standards for the programming function, securing alignment with oncology clinical development goals and department infrastructure needs.
• Submission Leadership: Act as the primary programming lead for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring all deliverables meet rigorous global standards.
• Analysis & Reporting: Direct the generation and validation of analysis datasets and TLFs, ensuring data integrity and regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11.
• Development, Standards, and Validation: Lead the development, validation, and review of efficient R code to support statistical analyses and deliverables. Enforce departmental standards for programming maintenance and code integrity. Facilitate cross-functional standards (eCRF design, DMPs).
• Infrastructure: Lead the development and maintenance of scalable programming infrastructure for the larger Biostatistics department.
• Interdisciplinary Partnership: Partner with Biostatistics, Clinical Operations, Data Management, and Regulatory to integrate programming expertise into clinical study execution.

QUALIFICATIONS

• Minimum 10 years of relevant industry experience supporting clinical trials in diagnostics, biotechnology, pharmaceuticals, or related industries. At least 5 years leading a team.
• Advanced degree in Biostatistics, Statistics, Computer Science, or a related field.

KNOWLEDGE, SKILLS, AND ABILITIES

• Expert working knowledge of R for clinical trial reporting; experience maintaining statistical packages and computing environments under version control
• In-depth knowledge of CDISC standards including SDTM and ADaM
• Proven track record of producing high-quality analysis output for regulatory audiences (FDA) and internal stakeholders.
• Proven record of hiring, mentoring, and developing a successful, productive team
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Exceptional problem-solving skills and attention to detail
• Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus