Site Name: Belgium-Wavre
Posted Date: Feb 22 2021
Job purpose :
As an Expert Biostatistician, you provide critical statistical expertise and technical support to the different vaccine studies. You are responsible for a whole study from design to execution for different study designs.
Your responsibilities :
In this role you :
- Identify the statistical methodology to establish study strategy (e.g. power modelling of different scenarios, set up power monitoring, set up mitigation plan to minimize the risk of statistical failure)
- Provide input for the protocol (design, objectives, endpoints, randomization strategy, sample size, stat analysis) and for the study set-up
- Develop Statistical Analysis Plans (involving sensitivity analysis to support the robustness of results) and coordinate review
- Review the TFL by coordinating the review with the Statistical Analyst and ultimately to approve the TFL
- Complete the QC of the statistical analysis methodology
- Validate study-specific dataset & analysis program specification
- Propose the SAR conclusion/s
- Prepare the answers for the study-specific statistical questions (e.g. inspections, questions from regulatory, etc.)
- Provide statistical support for possible independent analysis center/s
- Provide consultancy support/advice and trainings on statistical matters to other Statisticians
Basic Qualifications :
We are looking for professionals with the following required skills to achieve our goals (must-have):
- University degree: Master's or PhD or a Diploma in Sciences, Statistics, Biostatistics, Mathematics, Epidemiology or equivalent
- At least 5-year experience in the pharmaceutical industry
- Has been previously responsible for studies with different designs (dose range, superiority/non-inferiority, interim analysis rules,..)
- Experience in SAS software and sample size computation for standard designs including simulations
- Ability to work in a multidisciplinary team (e.g. give guidance to non-stat, provide feedback, engage), some being remotely located
- Be able to lead the development of new biometrics/epidemiological methods to gain efficiency and meet product development needs.
- Solutions driven develop solutions for non-standardization situation (process and statistical methodologies)
- Act at all times as the subject matter expert: provide statistical expertise in specific topics and training of peers.
- Truly acts as a mentor. Takes personal responsibility for supporting and developing others in the team.
- Demonstrates experience in leading working groups; motivates other team members by involving them in issues that affect them.
- Builds an environment that supports co-operation and cohesiveness among the work team; makes statements regarding common interests.
- Listens to team members; trusts them and responds to their requests for assistance.
- Be capable to work in a complex matrix organization and be flexible to work with different cultures and employees at different levels. Interaction will be expected with all teams based in Belgium, Netherlands, Germany, Italy, the US, UK and India.
- Good oral and written communication in English including the ability to explain difficult issues and situations clearly and ensures meaning is understood. Other languages a plus (French, Italian, etc.)
The following characteristics are assets (nice-to-have):
- Curious and keep up to date as a subject matter expert continuously seeking information from the internal and external environment to understand the wider business, scientific and/or commercial contexts.
- Actively contributes to set up standards.
- Interact and influence to build nonstandard solutions.
- Ability to work in a multidisciplinary environment and communicate effectively.
- Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions and execute brilliantly.
- Optimistic mindset.
- Influencing skills.
- Easy social networking/ interfacing.
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
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 .
Research and Development (R&D)
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.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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