Executive Director, Biostatistics — Oncology Trials

Scientific Search; Princeton (NJ); Remote; USD 250,000 - 300,000; Full time

Job summary

Scientific Search is seeking a Senior/Executive Director of Biostatistics to lead statistical strategy for solid tumor oncology programs in a remote role. You will oversee biostatistics and programming deliverables, guiding the clinical study team, data management, and regulatory submissions.

The role requires an MS in Statistics/Biostatistics with 5+ years’ experience, strong R programming, SAS experience preferred, and familiarity with CDISC standards, Medidata RAVE, and BLA/NDA interactions.

Qualifications

• Master's degree in Statistics or Biostatistics and 5+ years of relevant experience.
• Strong R programming skills required; SAS experience preferred.
• Experience in oncology and prior BLA/NDA filings with health authorities.

Responsibilities

• Design clinical trials with appropriate statistical principles.
• Provide statistical input to health authority interactions.
• Develop randomization plans where applicable.
• Align SAPs with data collection procedures and forms.
• Review outsourced statistical deliverables (SAPs, TLF shells, SDTM/ADaM).
• Provide programming support for publications and analyses.
• Maintain and modify in-house code.
• Collaborate with cross-functional study teams.

Skills

Biostatistics

Clinical trial design

R programming

Regulatory submissions

Education

Master's in Statistics/Biostatistics

Tools

Medidata RAVE

CDISC standards

Job description

Scientific Search is seeking a Senior/Executive Director of Biostatistics to lead statistical strategy for solid tumor oncology programs in a remote role. You will oversee biostatistics and programming deliverables, guiding the clinical study team, data management, and regulatory submissions.

The role requires an MS in Statistics/Biostatistics with 5+ years’ experience, strong R programming, SAS experience preferred, and familiarity with CDISC standards, Medidata RAVE, and BLA/NDA interactions.