Biostatistics Lead — Clinical Development & Regulatory Strategy

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

Benefits offered by this job

Health and welfare benefits

401(k) plan

Job summary

System One is seeking a Sr. Manager/Associate Director of Biostatistics in Wayne, PA, a hybrid role with 2 days onsite. You will guide statistical strategy for late-stage programs and influence study design, regulatory submissions, and potential commercialization.

The position requires a Ph.D. in Biostatistics (or MS with extensive pharma experience) and a track record of leading cross-functional teams, with expertise in SAS and R and strong regulatory knowledge.

Qualifications

• Ph.D. in Biostatistics or MS with substantial pharma experience.
• Proven statistical leadership for clinical programs and trials.
• Strong knowledge of trial methodology and regulatory requirements.

Responsibilities

• Lead biostatistics strategy for one or more development programs.
• Serve as statistical representative on cross-functional study teams and governance committees.
• Collaborate with Clinical Development and Medical teams on study design and endpoints.
• Provide input on statistical analysis plans, interim analyses, and decision criteria.
• Oversee analysis strategies and ensure regulatory-compliant outputs.

Skills

Statistical leadership

Study design

Regulatory knowledge

Cross-functional collaboration

SAS

R

Education

Ph.D. in Biostatistics

MS with relevant pharma experience

Tools

SAS

R

Job description

System One is seeking a Sr. Manager/Associate Director of Biostatistics in Wayne, PA, a hybrid role with 2 days onsite. You will guide statistical strategy for late-stage programs and influence study design, regulatory submissions, and potential commercialization.

The position requires a Ph.D. in Biostatistics (or MS with extensive pharma experience) and a track record of leading cross-functional teams, with expertise in SAS and R and strong regulatory knowledge.