Director, Clinical Statistical Programming

BioCryst Pharmaceuticals; North Carolina; On-site; USD 180,000 - 260,000; Full time

Job summary

BioCryst Pharmaceuticals seeks a Director of Statistical Programming to deliver leadership for complex clinical studies and NDA/BLA submissions. You will guide technical programming across internal and outsourced teams, ensuring regulatory readiness and expert data analyses with CDISC standards.

The role requires hands-on SAS, data management collaboration, and experience defending submission-ready datasets and outputs in a fast-paced environment.

Qualifications

• MS in Biostatistics, Computer Science, or related field with extensive pharmaceutical experience.
• Hands-on SAS programming with regulatory submissions and SDTM/ADaM knowledge.
• Experience leading complex studies and coordinating CRO/contractor work.

Responsibilities

• Provide technical programming strategy for complex studies and regulatory submissions.
• Lead CRO/contractor programming deliverables with clear specifications and reviews.
• Ensure QC, traceability, and inspection-ready documentation for submissions.
• Mentor programmers and enable cross-functional collaboration across Biostatistics and Data Management.

Skills

SAS programming

DATA step

SQL

macro programming

graphics for regulatory submissions

R

Python

Education

MS in Biostatistics or related field

Tools

CDISC standards

SAS

Job description

BioCryst Pharmaceuticals seeks a Director of Statistical Programming to deliver leadership for complex clinical studies and NDA/BLA submissions. You will guide technical programming across internal and outsourced teams, ensuring regulatory readiness and expert data analyses with CDISC standards.

The role requires hands-on SAS, data management collaboration, and experience defending submission-ready datasets and outputs in a fast-paced environment.