Your Responsibilities :
Within the Biostatistics & Stat Programming team of GSK Vaccines, biostatisticians provide statistical expertise and support in epidemiological studies in the development and life cycle of prophylactic or therapeutic vaccines.
• Be responsible for all statistical aspects of epidemiological studies in collaboration with internal and external stakeholders;
• Definition of study objectives and endpoints, choice of study design (in collaboration with the epidemiologist),
• Sample size calculation,
• Writing statistical sections for study synopses and protocols
• Input in study set up (case report forms, database, review of dataset specifications)
• 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)
• M.Sc. Degree, Ph.D. degree in Biostatistics or Epidemiology or equivalent qualification
• 3 years of experience as biostatistician in the Pharmaceutical field or in Epidemiology
• Understanding of applied statistical principles in the design and analysis of epidemiological studies.
• Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis in observational studies.
• Good Knowledge in epidemiology.
• Proficiency in SAS (knowledge of other statistical software is an asset)
• Compliance with internal Standard Operating Procedures and regulatory guidelines
• 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
• Previous experience with CDISC data is an asset
If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.
Why GSK? :
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com.
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.
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.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
You may apply for this position online by selecting the Apply now button.
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