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Manager Biostatistician - Navi Mumbai @ Glenmark

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 Manager Biostatistician - Navi Mumbai

Job Description

To provide Statistical insight to Clinical Development Plans (CDP), Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) across the approved products/Branded generic portfolio globally.
  • Analysis and interpretation of data for (Phases 1 to 4 studies) - Write and review Statistical Analysis Plan & Ouput.
  • Analysis and interpretation of data for Regulatory and Market access projects for Approved/Branded generic portfolio, including Devices.
  • Work efficiently with a SAS programming, study group and external providers.
  • High quality inputs in the study design (suggesting alternative designs and innovative/novel analyses methods)

Required Candidate profile

  • Require minimum of 5-8 years' experience in a similar senior role handling design and Analysis of Phase 1 to 4 clinical studies,
  • Responsibility for design and analysis plans for multiple studies using innovative analyses methods.
  • Direct exposure to mature market Regulator (FDA, EMA) desirable Respiratory therapeutic area knowledge's are (desirable).
  • Experience managing contractor/CRO staff (desirable).

If the above job description matches with your profile then please email your CV at va*******n@gl***********a.com

Job Classification

Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization, Graduation Not Required
Post Graduation: Post Graduation Not Required, Any Postgraduate in Any Specialization, M.Pharma in Pharmacy, MS/M.Sc(Science) in Any Specialization
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization, Ph.D in Advertising/Mass Communication

Contact Details:

Company: Glenmark
Address: Plot Number A 607, TTC Industrial Area, MIDC Mahape, NAVI MUMBAI, Maharashtra - 400707,India
Location(s): Mumbai

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Keyskills:   Biostatistician bio - statistics SAS Programming Clinical Development bio - mathematics

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Glenmark

Glenmark Pharmaceuticals Limited [Glenmark] is an India-based growing pharmaceutical company headquartered at Mumbai [formerly, Bombay]. Incorporated in 1977, the Company is focused on the manufacture and marketing of formulation products and active pharmaceutical ingredients [API] in India as well ...