AGM – Data Management & Biostatistics – Cadila Pharma
Assistant General Manager Position available at Cadila Pharma R&D Centre, Dholka.
Job opening posted in the R&D Centre of Cadila Pharmaceuticals at Dholka. The job profile involves heading of Data Management and Biostatistics process of CRO, reviewing clinical trial protocols for both internal consistency and across studies/ projects and reviewing Case Report Form (CRF) drafts for content, layout, protocol adherence and appropriate consistency with established standards; advising Biostatisticians on technical issues associated with the design, performance, and analysis of clinical trials, review and guide biostatisticians on statistical aspects of all FDA / other regulatory agencies interactions, including FDA / other regulatory meetings, responses to FDA / other regulatory questions, and Advisory Committee Meetings; providing leadership to therapeutic area Biometrics management team.
Additional responsibilities - to oversee set-up of data storage and transfer utilities and their testing, co-ordinate with sponsor on development of data review procedures, including edit check specifications, ensuring consistency between studies where appropriate, co-ordinate with sponsor on development of Data Management Plans, responsible for the statistical input provided by the group to all major documents, including clinical development plans, protocols, clinical study reports, summaries of clinical safety and efficacy.
Who can Apply?
- Ph.D./ Master’s in Statistics.
- Comprehensive understanding of theoretical and applied statistics, extensive experience in clinical trials, understanding of regulatory guidelines in a Pharmaceutical research setting.
- BLA/NDA development and submission experience required.
- Ability to effectively collaborate, communicate, and influence throughout all levels of the organization, strong leadership abilities.
How to Apply?
Contact:
Cadila Pharmaceuticals Limited
Email: careers@cadilapharma.co.in
Job Posting Source:
http://www.cadilapharma.com/Careers.htm
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