Bio Statistician

7 - 9 Years
Pune

Job Description

  1. Serves as the primary contact to clinical operations, data management, programming, medical writing and regulatory for all matters pertaining to statistics
  2. Consult on clinical trial design, sample size estimates and statistical methodology
  3. Validate statistical output to ensure that it accurately portrays the outcome of the clinical trail
  4. Relay topline results to the appropriate parties
  5. Review the CSR for accuracy with respect to the interpretation of the statistical analysis
  6. Develop & Review the statistical analysis plan and mock ups of tables, listings & figures
  7. Work with study team during (e) CRF development to ensure adequacy of data collection wrt statistical endpoints availability
  8. Prepare & Review ADaM mapping documentation
  9. Provide SAS programming support for data analysis & statistical reports
  10. Develop & execute QC programs datasets, tables & figures
  11. 4+ years of experience in the development of pharmaceuticals, biologics and/or medical devices
  12. Prior experience as a lead statistician
  13. Knowledgeable of all phases of clinical studies (Phase 1 4 clinical trials or medical devices)
  14. Ability to manage concurrent projects

Salary: INR 9,00,000 - 16,00,000 PA.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:R&D

Role:Clinical Research Associate/Scientist

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

PG:MS/M.Sc(Science) - Statistics

Doctorate:Ph.D - Statistics, Doctorate Not Required

Company Profile

LUPIN LIMITED

Lupin Limited is one of India's largest manufacturers of bulk actives and formulations. The principal bulk actives manufactured by it include Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives) and cardiovasculars. The company also possesses competencies in phytomedicines, in which medicines are made out of plant and herbal resources supported by the discipline of modern medicine.
View Contact Details+

Recruiter Name:Ridhi Prasad

Contact Company:LUPIN LIMITED