Executive Director, Biostatistics Greater San Francisco, CA Area

The Company is seeking an Executive Director of Biostatistics to lead statistical strategy for clinical programs in autoimmune diseases, from early-stage studies through potential pivotal trials. This hands-on role includes designing studies, defining endpoints and estimands, authoring statistical analysis plans, conducting complex analyses, and interpreting results to inform development decisions. The Executive Director will lead statistical input for regulatory interactions and submissions, scientific communications, and presentations to senior leadership and external stakeholders. They will also oversee vendor and CRO deliverables, establish analysis standards and quality practices, and build and lead biostatistics and statistical programming capabilities. Candidates must hold a PhD in Biostatistics or Statistics and have at least eight years of biopharmaceutical clinical-trial experience, including substantial program leadership; Executive Director consideration requires at least ten years. Required qualifications include deep experience in rheumatic or autoimmune diseases, hands-on expertise with relevant composite and responder endpoints, and leadership in pivotal study design, including power, sample size, multiplicity, and external-control approaches. Candidates must have experience with health-authority meetings and regulatory documentation, proficiency in SAS and/or R, and mastery of CDISC SDTM/ADaM standards. Strong communication and cross-functional leadership skills are essential, along with the ability to direct internal and external statistical teams.

Hiring Company

Nkarta, Inc.