As an expert Statistician, you will be responsible for a whole study from design to execution for different study designs.
- You use stat methodology to establish study strategy (e.g. power modelling of different scenarios, set up power monitoring, set up mitigation plan to minimize risk of stat failure)
- You provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
- You provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)
- You develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
- You review the TFL, to coordinate review with the stat analyst, to approve the TFL
- You do the QC of the statistical analysis methodology
- You validate study specific dataset & analysis pgm specification
- You approve deviation from TFL format
- You propose SAR conclusion
- You prepare answer to study specific stat question (e.g. inspection, RA question)
- You provide stat support to an independent analysis center
- You provide consultancy on stat matter for other statisticians
Why You?Basic qualifications:
- Master in Statistics, Mathematics, Epidemiology or equivalent
- At least 5-year experience in pharmaceutical industry
- Has been previously responsible for studies with different designs (dose range, superiority/non inferiority, futility rule,..)
- Experience in SAS software and sample size computation for standard designs
- PhD, MS or Diploma in Statistics, Mathematics or Epidemiology or equivalent
- Ability to work in multidisciplinary team (e.g. give guidance to non-stat, provide feedback, engage) , some being remotely located
- Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood
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.
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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