Head of Statistical Programming & Regulatory Analytics

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 180,000 - 240,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks an Executive Director, Statistical Programming in Durham, NC, to lead the statistical programming group responsible for analyses in regulatory submissions and publications.

The role requires extensive SAS expertise, leadership, and oversight of both in-house and outsourced activities. The position emphasizes strategy development, CRO oversight, data management collaboration, and adherence to GCP in biostatistics.

Qualifications

• MS in Biostatistics, Computer Science or related field with 15+ years in pharma.
• Extensive SAS programming experience.
• Experience with NDA/BLA submissions.
• Management of permanent staff.
• Experience with creating graphics for publications.

Responsibilities

• Develop vision and strategy for statistical programming group.
• Oversee CRO/contract staff for outsourced programming.
• Ensure regulatory submission readiness and data integrity.
• Lead capacity planning and department growth.
• Maintain SOPs and train staff.

Skills

SAS programming

Leadership

Regulatory submission

Biostatistics

Project management

Education

MS in Biostatistics or related field

Tools

SAS/GRAPH

SAS

Job description

BioCryst Pharmaceuticals, Inc. seeks an Executive Director, Statistical Programming in Durham, NC, to lead the statistical programming group responsible for analyses in regulatory submissions and publications.

The role requires extensive SAS expertise, leadership, and oversight of both in-house and outsourced activities. The position emphasizes strategy development, CRO oversight, data management collaboration, and adherence to GCP in biostatistics.