Contract Biostatistician- Remote, Inflammation, Immunology or Oncology

4 weeks ago

Kansas City, United States PharmaBiotech Company Full time

Contract Biostatistician- Remote, Inflammation, Immunology or Oncology experience a must.


Our client is a top tier pharmaceutical company is seeking contract Biostatistician’s for their Oncology and I&I groups. This role will involve implementing and executing methodological and statistical aspects of clinical studies under the supervision of a lead biostatistician. Will also function, develop & employ technical expertise in a particular statistical area or application.


Description:

Under supervision of senior level staff, you will provide support to a clinical study.

Work with study team on all relevant statistical matters and ensure the clinical study is conducted in a manner that supports planned statistical analysis.

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 and participate in project related activities including preparation of BLA submissions and oversee CRO deliverables for studies contracted out.


Required:

Phd / Master Degree in Statistics.

3-8 years of experience as a Statistician.

Experience must be within the industry, Pharmaceutical/Biotech or combination of CRO and Pharma.

Strong SAS/Statistical programming skills.

**12 month contract, renewable

**Pay rate - mid to senior level (flexible)

**No 3rd parties**

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