Temp - Biostatistician - Early Clinical Development

$124,800 - $145,600/Yr

System One - Tarrytown, NY

Full-time - Entry Level

Remote - Tarrytown, NY

Administrative and Support Services

About the position

The Biostatistician - Early Clinical Development role is a contract position within a global pharmaceutical company, focusing on the statistical aspects of early phase clinical trials. The position requires collaboration with clinical study teams to ensure studies are conducted in alignment with statistical analysis plans, and involves tasks such as sample size calculations, protocol preparation, and statistical analysis.

Responsibilities

• Provide support to a clinical study team on all relevant statistical matters under the supervision of senior staff.
• Ensure the clinical study is conducted in a manner that supports planned statistical analysis.
• Participate in the preparation of study protocol and amendments under guidance.
• Perform sample size calculations and write the statistical methodology section of the protocol.
• Review case report forms (CRF) and provide comments and feedback.
• Develop statistical analysis plans (SAP).
• Provide programming team with definitions and documentation for derived variables needed for planned Tables, Figures, and Listings (TFLs).
• Perform statistical analysis according to the SAP, validate analysis programs, and review TFLs.
• Prepare statistical methods and results sections for the clinical study report (CSR).
• Provide statistical insight into interpretation and discussion of study results and assist in moving the CSR through the review/approval process.
• Support project-related activities including preparation of BLA submissions and oversee CRO deliverables.

Requirements

• Master's Degree in Statistics/Biostatistics or a related field required.
• 2+ years of relevant experience in early phase clinical trials.

Benefits

• Health and welfare benefits coverage options including medical, dental, and vision insurance.
• Life insurance and voluntary plans.
• Participation in a 401(k) plan.