Biostatistician

2 months ago


bangalore, India Lifelancer Full time

About the job

Job description:

The incumbent will provide statistical expertise and contribution in the conduct of human subjects research during clinical development and life cycle management.

As a study biostatistician for statistically standard clinical studies and under supervision:

act as Statistical subject matter expert at study team level

provide statistical input for concept sheet/protocol/CRF development (e.g., study design; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough statistics section; effective CRF specifications to collect data specified in the protocol, ensure blinding/unblinding measure are taken to ensure data integrity) with supervision.

author medical and statistical supervision plans, write statistical analysis plans including the most appropriate statistical methodology and data presentations and provide specifications for analysis datasets.

perform statistical analyses or validate statistical output as required or able to conduct oversight of vendor for these studies.

write comprehensive statistical methods sections for the clinical study report; critically review and coauthor these reports ensuring the accuracy of the statistical interpretation.

With supervision, able to effectively perform adhoc analysis or project related standard reporting (e.g., DSUR).

understand and follow all Global Biostatistics WIs/SOP and relevant Standards as well as any other relevant WIs/SOPs.

May act as an interface between programming and statistic. The responsibilities include but are not limited to performing complex statistical analyses.

Requirement:

MS in Statistics, Biostatistics or related discipline

Fluent in English (written and spoken)

Skills:

SAS and R practical and effective knowledge

Ability to develop an understanding of relevant clinical therapeutic areas

Results driven

Collaborative

Act purposefully


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