Biostatistics Strategy Lead — Global Clinical Analytics

BioCryst Pharmaceuticals

Boston (MA)

Remote

USD 180,000 - 240,000

Full time

3 days ago

Be an early applicant

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

BioCryst Pharmaceuticals is seeking an Executive Director of Biostatistics to lead statistics for BioCryst-sponsored clinical studies from Phase I to IV, including non-clinical studies. You will guide statistical thinking, ensure GCP conformance, and drive outsourcing strategy aligned with Biostatistics & Data Science goals.

The role demands deep study design, regulatory strategy, programming expertise, and the ability to manage and mentor a team across global sites.

Qualifications

Ph.D. in Biostatistics (or related field) with at least 12 years' experience in the pharmaceutical industry, 10+ years in design, analysis and interpretation of clinical trials.
Proven expertise with SAS programming and ability to oversee statistical programming.
Experience with Bayesian and frequentist statistics; regulatory guidelines knowledge.

Responsibilities

Lead Biostatistics support for BioCryst-sponsored clinical studies and selected non-clinical studies.
Ensure appropriate statistical methods and regulatory conformance (GCP).
Oversee outsourced CRO/contract staff; review contracts and invoices.
Act as project statistician; participate in FDA/regulatory meetings as spokesperson.
Drive process improvements in biostatistics and programming; monitor performance metrics.