Manager - Biostats - Pharma

We are having an opportunity for the position of a Manager Biostats with a leading pharma company for the location of Mumbai

Experience - Min 3+ years

CTC - Best in the industry

Please find below the job role for a better clarity & understanding-

1. Responsible for all aspects of statistical planning, methodology and analysis or oversight of such tasks performed by the external vendor.

2. Review CRF database and dataset structure, data management plan, data quality plan, data review guidelines and edit specifications.

3. Provide input into clinical study protocol and create / review / approve statistical analysis plan SAP.

4. Interface with in-house staff: Participate on project teams, Review monitoring guidelines and clinical study reports, work closely with medical monitors and KOLs to design statistically sound and viable clinical trials.

5. Work with internal staff or vendors to assure that all programming and statistical analyses are properly conducted and validated to allow for proper analysis and interpretation required for inclusion into report and regulatory.

6. Assist director, biostatistics in identification, creation and maintenance of department's procedures.

7. Participate in department initiatives related to process building and improvements.