Director of Statistical Programming

Director, Statistical Programming | Oncology Biotech (Late-Stage)Location: Remote (East Coast Preferred)Reports into Sr. Director – Head of BiostatsSalary: $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 OutOwn programming strategy across late-stage oncology programsLead global submissions (NDA/BLA/MAA) and integrated analysesDrive innovation using R, Python, and modern data platformsPartner directly with Biostatistics, Clinical, and executive stakeholdersBuild and scale processes in a growing, fast-moving biotech environmentWhat you’ll be doing:Leading integrated safety and efficacy analyses (ISS/ISE) at the program levelOverseeing global programming operations and vendor partnershipsDriving submission readiness including TLFs, define.xml, and reviewers’ guidesEstablishing scalable, audit-ready programming standards and SOPsActing as a senior leader across cross-functional clinical teamsWhat they’re looking for:15–18+ years in pharma/CRO with deep experience in oncology programmingProven leadership in global submissions and integrated analysesStrong expertise in SAS, CDISC (SDTM/ADaM), and regulatory standardsTrack record leading global teams and managing external vendorsThis 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.