Biostatistician

Job Title:

Bio Statistician

Business Unit:

MACR

Grade:

Location:

Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

YOUR TASKS AND RESPONSIBILITIES:

- Preparation and Review of Statistical Analysis Plan (SAP) and MOCK Shells

- Provide statistical inputs for the clinical trial protocol

- Determination of sample size for Phase II, III and IV clinical trials

- Generation of randomization schedule

- SAS Programming specifications for analysis datasets, Table, Listing and Figures (Efficacy and safety tables)

- QC of Table, Listing and Figures (Efficacy and safety tables)

- Review of SAS annotated Case Report Form as per the CDISC standards and other study documents to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis

- Statistical analysis of clinical trial data

- Coordination with statistical programmer on assigned projects to ensure timely completion of high quality work

- Review of Clinical study report from statistical aspects ensuring that results are captured in consistent with the analysis described in the SAP

- Preparation and Review of SAS and Biostatistics related departmental SOPs

Job Requirements

Educational Qualification

PG in Biostatistician Mandatory.

Experience

3-5 years’ experience in Biostatistician in clinical.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS The role is majority office based but will involve an average 8 to 10 days of travel outside Mumbai.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).