Temp Biostatistician

Regeneron; Village of Tarrytown (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in Tarrytown is seeking a Biostatistician to implement methodological and statistical aspects of clinical studies. The role involves providing support to the clinical study team, preparing study protocols, and performing statistical analyses. Candidates should hold a Master's degree with at least 2 years of relevant experience. This position offers an opportunity to work closely with senior staff in a collaborative environment.

Qualifications

• Master's degree in a related field is required.
• 2 years of relevant experience is mandatory.

Responsibilities

• Support clinical study team with statistical matters.
• Participate in preparation of study protocol and amendments.
• Review case report forms and provide feedback.
• Develop statistical analysis plan and specifications.
• Perform statistical analysis and validate analysis programs.
• Participate in project-related activities and oversee CRO deliverables.

Skills

Statistical analysis

Clinical study support

Statistical methodology

Data analysis

Education

Master Degree in related field

Job description

Overview

Biostatistician - R45646

The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of the Therapeutic Area lead biostatistician or project lead statistician. In some cases, the principal function could be to develop/employ technical expertise in a particular statistical area or application.

Responsibilities

• Under direct supervision and guidance of senior departmental staff, provide support to a clinical study team on all relevant statistical matters. As a member of the study team, ensure the clinical study is conducted in a manner that supports planned statistical analysis.
• Under supervision and guidance of senior departmental staff, participate in preparation of study protocol and amendments. Perform relevant sample size calculations and write statistical methodology section of the protocol.
• Review case report form (CRF) and provide comments and feedback.
• Develop statistical analysis plan (SAP).
• Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures and Listings (TFLs). Develop data and programming specifications jointly with programmers.
• Perform statistical analysis according to the SAP, validate analysis programs, 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 work with the study team to move the CSR through review/approval process.
• Support/participate in project-related activities including preparation of BLA submissions and oversee CRO deliverables for studies contracted out.

Qualifications

• Master Degree in related field required
• 2 years of relevant experience