Expert Biostatistician - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Belgium-Wavre

Posted Date:
Mar 8 2023

Job Purpose

To provide stat expertise to support the different study designs

Key Responsibilities

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_:

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 nonstat, 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.

Find out more:
Annual Report 2021

We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why.

We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:
Our approach to R&D.

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.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

**Important notice to Employment businesses/ Agencies