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