Expert Biostatistician

Site Name:
UK - London - Brentford, Amsterdam, Wavre

Posted Date:
Jul

Expert Biostatistician - Vaccines

Vaccines Statisticians are at the forefront of transformations in the vaccines industry to combat the spread of infectious diseases and treat chronic conditions to the benefit of millions of people worldwide.

Supporting all phases of vaccines development, Vaccines Statistics is a highly effective and influential strategic partner consisting of five groups
:Clinical Assay Statistics,
Early and Exploratory Clinical Statistics, and three
Clinical and Epidemiological Statistics groups aligned to the Global Vaccines Research and development Centres in
Belgium,
Italy, and the
US.

Join our team of cutting-edge experts in data analysis and methodologic research in embedding quantitative decision-making in order to take smart risks and improve the probability of study and program success.

Our end-to-end project support model ensures that our statisticians collaborate across the entire range of drug development, from early clinical development to registration and marketed product support.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

In this role you will be responsible for a whole study from design to execution for different study designs:

• To use stat methodology to establish study strategy modelling of different scenarios, set up power monitoring, set up mitigation plan to minimize risk of stat failure)
• To provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
• To provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)
• To develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
• To review the TFL, to coordinate review with the stat analyst, to approve the TFL
• To do the QC of the statistical analysis methodology
• To validate study specific dataset & analysis pgm specification
• To approve deviation from TFL format
• To propose SAR conclusion
• To prepare answer to study specific stat question (e.g. inspection, RA question)
• To provide stat support to an independent analysis center
• To provide consultancy on stat matter for other statisticians

_ Why you?_

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• MS or MSc in a Statistical discipline with relevant experience in clinical research, Pharmaceutical, CRO or Academic setting
• 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
• Ability to work in multidisciplinary team (e.g. give guidance to nonstat, provide feedback, engage), some being remotely located
• Demonstrable understanding of Bayesian techniques
• Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• PhD in Statistical discipline
• Demonstrated ability to explain novel and standard methods to scientific and clinical colleagues
• Strong influencing skills applied effectively across functions and levels of an organization.

Closing Date for Applications - 13th August 2023 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.

LI-GSK

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Emplo

---