- M.Sc. Degree, Ph.D. degree in Biostatistics or Epidemiology or equivalent qualification.
- 2-4 years of experience as Biostatistician in the Pharmaceutical field or in Epidemiology.
- Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analyses of clinical studies.
- Understanding of applied statistical principles in the design and analysis of clinical and/or epidemiological studies.
- Good Knowledge in clinical development.
- Proficiency in SAS (knowledge of other statistical software is an asset).
- Knowledge in ICH, FDA and EMA regulations and CDISC.
- Good skill in written and spoken English is a MUST.
- 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.
Please see "Basic Qualifications".
Within the Biostatistics & Statistics Programming team of GSK Vaccines, Biostatisticians provide statistical expertise and support in clinical studies in the development and life cycle of prophylactic or therapeutic vaccines.
- Participate in the clinical 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, value results with statistical methods to support strategical decisions.
- 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).
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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