Serum Institute of India, Biostatistician
Job Description
Position : Biostatistician
Education
Post Graduate Degree / CA / CS , PhD / Doctorate
Location : Pune
Job Description:
Biostatistical applications for clinical research Department
Coordination with different internal customers like R&D , QA , QC, R.A. etc
Coordination with different external agencies and regulatory agencies.
Designing, implementing, analyzing & reporting trials as per GCP, GCDMP guidelines.
Contributing in the development of the clinical trials protocol and CRFs.
Expertise in handling, analyzing and reporting multi centric clinical trials data.
Knowledge about regulatory procedures and submissions.
Experience in medical writing and developing clinical study report
Designing and implementing data management and statistical analysis plans
Good knowledge of SAS, which would provide bio-statistical inputs in the study design analysis planning, statistical analysis, interpretations, for phase I, II & III clinical studies.
Specifications
Education Qualification : PhD / M.Tech / M.Sc. (Statistics / Biostatistics)
Experience : 10 to 15 Yrs ( Related Industrial experience)
• The ideal candidate should have experience in leading Biotech / biopharmaceutical company
• Understanding of regulatory compliance and guidelines of different Regulatory Authorities.
• Knowledge of cGMP is an advantage.
Technical / Functional Skills
• Good verbal and written skills are needed.
• Extensive skill, knowledge, and experience are needed for this position.
• Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
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