Title:  Senior Biostatistician

Job Location: Bangalore

Department: Biostatistics

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 Description:

Role - Senior Biostatistician

Key Responsibilities: 

• Reviewing Synopsis/Protocol
• SAP (Text and Mock shell) preparation and implementation.
• Literature review and Sample size estimation.
• Provides statistical consideration and study design.
• Preparing and reviewing randomization list.
• Provides support for blinding and unblinding documentations.
• Preparing and reviewing of tables, listing and graphs, as applicable.
• Preparing and reviewing of statistical report, as applicable.
• Preparing and reviewing standard operating procedures.
• Training/Guiding/Mentoring associate biostatisticians and junior programmers.
• Driving project progress with biostatisticians and junior programmers.
• Attending client meeting to answer statistical queries.
• Support for CDISC standard (ADaM datasets)
• Facing Audit/Inspection
• Support and answering to regulatory queries
• Review of SAS data sets for statistical analysis, Tables and Listings in a standard format.
• Responsible for review of SDTM and ADaM data sets.
• Perform quality checks on the data or deliverables.
• Reviewing of tables, listing and graphs, as applicable

Educational Qualification: 

M.Sc. Statistics

Experience: 

3 - 6 Years

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.