NHS Human Services, Inc.

Reference #: 399418 Site Name: GSK HQ, Stevenage, Upper Merion Posted Date: Jun 26 2024

We are looking for an Associate Director of Statistics to join our Speciality and Primary Care Statistics team.

Statisticians are highly prized and urgently needed at GSK to grow an industry-leading team who put quantitative rocket boosters under every project we touch and transform the pace, scale and success with which our company serves the patients who rely on us.  We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical methodology to drive key contributions to the research and development of new medicines and vaccines in our three clinical areas: Oncology, Speciality and Primary Care (our non-oncology therapy areas) and Vaccines.

GSK Specialty and Primary Care Statistics is proud to support drug development efforts in Immunology, Hepatology, Gastro-intestinal, Renal, Respiratory, Cardiovascular, Neuroscience, Infectious Diseases, HIV, and Global Health (which covers infectious diseases like malaria and TB that impact the developing world).

Join our team of industry-leading statistician experts in data analysis and methodologic research in embedding quantitative decision-making to take smart risks and improve the probability of study and program success. Our end-to-end project support model ensures that our clinical statisticians collaborate across the entire range of clinical drug development, from early clinical development, to registration, approval, and marketed product support.  We have individual contributor career opportunities across a range of experience levels from entry-level to industry-experienced biostatisticians.

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

This opportunity is to join the Respiratory Disease Area team to develop new medicines to treat a wide range of respiratory diseases.  While GSK has been an industry leader in improving lives of respiratory patients for many decades, this is an especially exciting time to be in Respiratory at GSK, as we are growing our portfolio, evaluating novel approaches to treatment and prevention that could further reduce the impact of respiratory illnesses on the health and wellbeing of millions of patients worldwide.

This Statistics Associate Director position will provide statistical leadership in support of one or more Respiratory programs. This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

Apply statistical innovation and expertise to specific products throughout their GSK life cycle, in terms of both design and analysis of clinical trials and observational data.

Set statistical strategy in alignment with overall product strategy.

Proactively influence external opinion leaders and regulatory authorities related to Statistics methodology.

Ensure Statistics product and project strategies are robust and effectively defended in interactions with senior internal groups and with regulatory authorities, external expert groups, lawyers and other companies.

Responsible for the statistical validity of data dissemination related to supported programs.

Prepare and deliver Headline Reports and related disseminations of results from GSK clinical studies

Lead and deliver asset level pooled/meta-analyses of internal and external clinical trials and observational data.

Member of and key contributor to various GSK teams (Medicine Development, Clinical Matrix, Global Collaborative Trials, Data Dissemination, etc...).  Effective partnership with Medicines Development Leaders, Clinical Investigations Leaders, and others.

Direct collaboration with and oversight of 3rd parties in fulfillment of responsibilities supporting GSK programs, including capacity management and trouble-shooting problems related to project delivery

Understand, assess and communicate Statistics aspects of project strategies & deliverables to key stakeholders.

Provides statistics training and education to various areas of the company.

Ensure appropriate interpretation and use of internal and external interventional and observational data.

Support Disease Area Head of Respiratory Statistics and others in relationship to Statistics governance and procedural documentation, functional capability development, compliance, best practices, training and recruitment.

Accountable for statistical (e.g., randomization/blinding/unblinding, protocol development, analysis planning, ADaM and TLF) deliverables and key milestones for supported projects. Consults with Programming and Data Management colleagues regarding deliverables relating to programming and data management activities, including but not limited to: database set up, data standards (CDISC), analysis database conversions (eg, ADaM), data repository, and data re-use.

Statistical approval for regulatory correspondence, submissions, protocols, reports, and other deliverables.

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

Masters in Statistics/Biostatistics or other subject with high statistical content & extensive experience OR PhD along with strong knowledge, experience and understanding of statistics for drug development, including clinical development and/or post-marketing

Post-graduate statistical experience in the pharmaceutical industry or medical research including:

Independent leadership of the design, analysis and reporting of at least 1 complex and/or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia

Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements

Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal and external audiences

High learning ability, strong technical skills and demonstrated ability to learn and apply new statistical methods on-the-job

Strong verbal and written communication skills with demonstrated ability to explain novel and standard methods to scientific and clinical colleagues.

Preferred Qualifications: If you have the following characteristics, it would be a plus:

Experience in advanced innovative statistical methodology, including:

Bayesian methods

Longitudinal Modelling

Causal Inference

Machine Learning or Large-Language Models

Experience developing medicines for treating respiratory diseases Closing Date for Applications - 10th July (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to a