Lead-Biostatistician

Designation: Lead-Biostatistician

Job Location:Bangalore

Department:Biometrics

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose (1-2 Lines):To perform Biostatistical activities in Biometrics Department for Clinical Studies Phase 1-4

Key Responsibilities:(Maximum 5-8 Points)

• Reviewing protocol


• SAP & RAP preparation and implementation


• Sample size calculation


• Provides statistical consultations


• Preparing and reviewing randomization list


• Preparing and reviewing of tables, listing and graphs, as applicable


• Preparing and reviewing of statistical report, as applicable


• Provides support for blinding and unblinding documentations


• Preparing and reviewing standard operating procedures


• Training/Guiding/Mentoring associate biostatisticians and junior programmers.


• Objectives setting and appraisal for the team


• Facing client to answer statistical queries

Any other responsibilities assigned by the organization from time to time

Educational Qualification:M. Sc. in Statistics, Ph. D. in Statistics or any equivalent degree in Statistics

Technical/functional Skills: (Maximum 4-6 Points)

Expert in any programming language (preferably R and SAS)

Clinical Trials Exposure Pharmacokinetics and Phase I-IV

Experience:

Behavioral Skills:

Equal Opportunity Employer:

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