Director of Statistical Programming – Submissions & Strategy

BioCryst Pharmaceuticals, Inc.; North Carolina; Híbrido; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

BioCryst Pharmaceuticals, Inc. is seeking a Director of Statistical Programming to lead technical programming for complex clinical studies and NDA/BLA submissions.

You will oversee internal and outsourced programming, ensuring audit-ready datasets and adherence to CDISC standards, while mentoring staff across functions. The role requires SAS expertise, experience with regulatory submissions, and strong collaboration with Biostatistics, Data Management, and Regulatory Affairs to maintain quality

Formación

• MS in Biostatistics, Computer Science, or related field with 10+ years in pharma/biotech programming.
• Extensive hands-on SAS programming experience required.
• Experience leading complex studies or submissions without direct people management.

Responsabilidades

• Provides technical programming strategy for complex studies and submissions.
• Leads and mentors programmers across internal and CRO teams.
• Ensures regulatory-ready datasets, outputs, and traceability for NDA/BLA work.
• Reviews CRO deliverables, manages timelines, and maintains quality oversight.
• Develops high-quality tables, listings, and figures for regulatory submissions.

Conocimientos

SAS programming

CDISC standards

Statistical programming leadership

Regulatory submissions (NDA/BLA)

CRO/vendor management

Data analysis & visualization

Programming mentorship

Educación

MS in Biostatistics, Computer Science, or related field

Herramientas

SAS

R

Python

CDISC tooling

Descripción del empleo

BioCryst Pharmaceuticals, Inc. is seeking a Director of Statistical Programming to lead technical programming for complex clinical studies and NDA/BLA submissions.

You will oversee internal and outsourced programming, ensuring audit-ready datasets and adherence to CDISC standards, while mentoring staff across functions. The role requires SAS expertise, experience with regulatory submissions, and strong collaboration with Biostatistics, Data Management, and Regulatory Affairs to maintain quality