GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products. GSK Vaccines is a world’s leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis.
Job Title : Biostatistician
Requisition ID : WD89661
Position: Full-Time Regular
Functional area : Science and Technology
Location: Wavre, Bangalore
Basic qualifications:
- M.Sc. or Ph.D. degree in Biostatistics or Epidemiology
- 2-4 years of experience as biostatistician in the Pharmaceutical field
Preferred qualifications:
- Comprehensive understanding of applied statistical principles and modeling in the design and analysis of clinical trials / epidemiological studies.
- Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis in either observational studies or randomized studies.
- Knowledge in epidemiology (for the biostatistician position in epidemiology)
- Proficiency in SAS (knowledge of other statistical software is an asset)
- Good skill in written and spoken English
- Ability to easily communicate with different functions: clinicians, scientists, data managers, scientific writers, commercials, etc. in an international, multi-cultural environment
- Compliance with internal Standard Operating Procedures and regulatory guidelines
- Experience in cDISC is an asset.
Job Purpose : provide statistical expertise and support in the development of prophylactic or therapeutic vaccines.
Key Responsibilities:
As biostatistician, you will:
- participate in the clinical/epidemiological development plan (trial designs, sample sizes, interim analysis, etc.) in collaboration with clinical development managers, safety physicians, clinicians and epidemiologists. In particular, provide statistical, and scientific input into clinical development planning
- be responsible for the statistical designs of clinical/epidemiological studies, creating statistical sections for study synopses and protocols
- input in study set up (case report forms, database, randomization)
- explore new statistical approaches and methodologies through innovative and creative thinking
- propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
- write and execute SAS programs to analyze the data and to report results creating tables and standard listings
- perform statistical analysis, run simulations and discuss with internal and external experts
- support scientific writers and clinicians to correctly interpret the statistical results and align them with the clinical report conclusions
- write the statistical sections of clinical study reports, statistical publications and prepare materials for publications and create statistical text for clinical study communications
- input in standard processes (review of Standard Operating Procedures, guidelines, definition of new processes needed)
