Expert Biostatistician

Key Skills

Biostatistics, Effective communication skills

Job Description

Key Responsibilities

Responsible for a whole study from design to execution for different study designs:

• to 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)
• 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

Qualifications

• at least 5-year experience of 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
• 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

Why GSK

Uniting science, technology and talent to get ahead of disease together

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 impact the health of 2.5 billion people around the world in the next 10 years.

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.