Biostatistician - Internal Medicine

$135,200 - $156,000/Yr

System One - Tarrytown, NY

Full-time - Entry Level

Remote - Tarrytown, NY

Administrative and Support Services

About the position

The Biostatistician - Internal Medicine position is an entry-level contract role within a global pharmaceutical company. The primary focus is to support clinical studies by implementing and executing statistical methodologies under the guidance of senior biostatisticians. This role involves collaboration with clinical study teams to ensure that studies are conducted in alignment with statistical analysis plans, contributing to the preparation of study protocols, and performing statistical analyses to support clinical research in Internal Medicine.

Responsibilities

• Provide support to a clinical study team on all relevant statistical matters under direct supervision.
• Ensure the clinical study is conducted in a manner that supports planned statistical analysis.
• Participate in the preparation of study protocol and amendments under supervision.
• Perform relevant 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 to produce 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 the interpretation and discussion of study results and work with the study team to move the CSR through the review/approval process.
• Support/participate in project-related activities including preparation of BLA submissions and oversee CRO deliverables for contracted studies.

Requirements

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

Benefits

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