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 tom@scientificsearch.com to learn more.