Director of Statistical Programming

Director, Statistical Programming | Oncology Biotech (Late-Stage)

Location: Remote (East Coast Preferred)

Reports into Sr. Director – Head of Biostats

Salary: $210‑225k base (flexible to go higher for the right individual).

We’re partnering with a 100+ person oncology company entering a critical phase of growth, with multiple programs advancing toward global submissions. This is a high‑visibility leadership role where you’ll shape programming strategy across pivotal studies and regulatory filings.

If you’ve led ISS/ISE, global submissions, and high-performing programming teams , this is the kind of role where you can truly influence outcomes.

Why This Role Stands Out

• Own programming strategy across late-stage oncology programs
• Lead global submissions (NDA/BLA/MAA) and integrated analyses
• Drive innovation using R, Python, and modern data platforms
• Partner directly with Biostatistics, Clinical, and executive stakeholders
• Build and scale processes in a growing, fast-moving biotech environment

What you’ll be doing

• Leading integrated safety and efficacy analyses (ISS/ISE) at the program level
• Overseeing global programming operations and vendor partnerships
• Driving submission readiness including TLFs, define.xml, and reviewers’ guides
• Establishing scalable, audit-ready programming standards and SOPs
• Acting as a senior leader across cross‑functional clinical teams

What they’re looking for

• 15–18+ years in pharma/CRO with deep experience in oncology programming
• Proven leadership in global submissions and integrated analyses
• Strong expertise in SAS, CDISC (SDTM/ADaM), and regulatory standards
• Track record leading global teams and managing external vendors

This is an opportunity to step into a strategic leadership role at a company where your work will directly impact regulatory success and patient outcomes.

Message me directly or email to learn more.

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