ApplyDescription
We are seeking a highly motivated Senior Director / Head of Statistical Programming to establish and lead the programming function in a dynamic biotech environment. This role combines strategic leadership with hands-on technical contribution, supporting early- to late-phase oncology and other therapeutic programs. The successful candidate will oversee programming deliverables for clinical trials and regulatory submissions, manage CROs, and build internal capabilities to enable data-driven decision-making and accelerate drug development.
Key Responsibilities
Leadership & Strategy- Define and lead the statistical programming vision, strategy, and operating model in a growing biotech setting.- Serve as the functional lead for programming across all studies and development programs.- Provide expert input into protocol design, SAP development, and regulatory strategy.Execution & Delivery- Oversee and contribute to the creation of high-quality analysis datasets (ADaM), TFLs, and SDTM conversions to support clinical study reporting and regulatory submissions.- Act as programming lead for NDA/BLA/MAA deliverables, ensuring compliance with CDISC, ICH, and regulatory standards.- Implement efficient processes, templates, and standards to maximize quality and productivity in a resource-constrained environment.- Proactively troubleshoot and provide technical solutions for complex programming challenges.Collaboration & Oversight- Partner closely with Biostatistics, Data Management, Clinical, and Regulatory teams to ensure alignment and timely delivery.- Manage and oversee CROs/vendors, ensuring deliverables meet quality, cost, and timeline expectations.- Represent statistical programming in cross-functional governance meetings, study teams, and regulatory interactions.Team Building & Mentorship- Recruit, mentor, and develop a small but high-impact programming team.- Foster a culture of collaboration, accountability, and continuous learning.- Provide training, technical guidance, and career development support to staff.
Why Join Us
- Opportunity to shape and build the statistical programming function in a growing biotech.- High-impact role with direct influence on advancing innovative therapies to patients.- Collaborative, entrepreneurial culture with strong scientific focus.- Competitive compensation, equity participation, and comprehensive benefits.Requirements- MS/PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related field. - 10+ years of statistical programming experience in the pharmaceutical/biotech industry, with proven experience leading programming support for regulatory submissions.
- Strong hands-on programming expertise in SAS; proficiency in R and/or Python highly desirable. - Excellent knowledge of CDISC (SDTM, ADaM), ICH, and regulatory guidance. - Demonstrated success managing CROs and delivering results in a fast-paced, resource-lean biotech environment. - Strong leadership, communication, and problem-solving skills, with ability to influence and collaborate across functions. - Passion for building teams and infrastructure from the ground up.
Salary Details
$250k - $300k yearlySalary Description$250k - $300k
