Senior Biostatistics Lead – Strategy & Regulatory Submissions

System One Clinical & Science; Wayne (PA); Hybrid; USD 175,000 - 200,000; Full time

Job summary

System One Clinical & Science in Wayne, PA seeks a Sr. Manager/Associate Director of Biostatistics to lead statistical strategies for late-stage programs. The role partners with Clinical Development, Medical and regulatory teams to shape study design, analyses, and regulatory submissions.

The ideal candidate holds a Ph.D. in Biostatistics or related field with extensive pharma experience, demonstrates leadership across cross-functional teams, and guides external CROs and statisticians to deliver

Qualifications

• Ph.D. in Biostatistics or related field required or an MS with significant pharma experience.
• 6+ years in pharmaceutical industry with clinical statistics leadership.
• Experience supporting regulatory submissions and health authority interactions.
• Strong knowledge of trial design, endpoints, and regulatory standards.
• Ability to manage CROs and external statisticians.

Responsibilities

• Lead biostatistics strategy for multiple clinical development programs.
• Collaborate with cross-functional teams on study design and analysis plans.
• Prepare statistical sections of SAPs and study reports.
• Develop and oversee TLFs and analysis deliverables.
• Support regulatory interactions and submissions.
• Ensure compliance with ICH, FDA, EMA guidelines.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory knowledge

Clinical trial design

Data interpretation

Education

Ph.D. in Biostatistics or related field

M.S. in Biostatistics or related field

Tools

SAS

R

Job description

System One Clinical & Science in Wayne, PA seeks a Sr. Manager/Associate Director of Biostatistics to lead statistical strategies for late-stage programs. The role partners with Clinical Development, Medical and regulatory teams to shape study design, analyses, and regulatory submissions.

The ideal candidate holds a Ph.D. in Biostatistics or related field with extensive pharma experience, demonstrates leadership across cross-functional teams, and guides external CROs and statisticians to deliver