Sr. Director, Biostatistics

Scorpion Therapeutics; Winston-Salem (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Director of Biostatistics to lead the statistical strategy for ProKidney's pivotal Phase 3 program, oversee design, analysis, and regulatory reporting, and drive FDA-facing interactions.

The role requires a Ph.D. in Statistics or Biostatistics, 10+ years in biopharma with late-stage trials, and strong SAS/R/Python proficiency, with oversight of internal teams and external vendors.

Qualifications

• Ph.D. in Statistics, Biostatistics, or related field.
• 10+ years in biopharma with extensive experience in late-stage clinical trials.
• Experience with BLA/NDA submissions.
• Strong FDA-facing expertise.

Responsibilities

• Oversee study design, analysis plans, data interpretation, and reporting for regulatory submissions.
• Lead biostatistics team.
• Manage external vendors.
• Contribute to FDA interactions.
• Support integrated safety analyses.

Skills

FDA submissions experience

Biostatistics leadership

Education

Ph.D. in Statistics or Biostatistics

Tools

SAS

R

Python

Job description

Role

Senior Director, Biostatistics leading ProKidney's pivotal Phase 3 clinical trial program, responsible for statistical strategy, analysis, and regulatory reporting.

Responsibilities

• oversee study design, analysis plans, data interpretation, and reporting for regulatory submissions
• lead biostatistics team
• manage external vendors
• contribute to FDA interactions
• support integrated safety analyses

Requirements

• Ph.D. in Statistics, Biostatistics, or related field
• 10+ years in biopharma with extensive experience in late-stage clinical trials, including biologics or cell therapies
• proficiency in SAS, R, or Python
• experience with BLA/NDA submissions
• strong FDA-facing expertise

High-Value

• Phase 3 biologics/Cell therapy trial, regulatory deliverables, cross-functional collaboration with data management, data science, pharmacovigilance, and leadership
• experience with complex data models and nontraditional logistics

WorkSetup

not specified; likely office-based with industry-standard expectations.