Statistics Leader / Associate Director, Oncology Clinical Development
Client:
GSK
Location:
Stevenage
Job Category:
Other
EU work permit required:
Yes
Job Reference:
4c5b9265e31a
Job Views:
5
Posted:
13.02.2025
Expiry Date:
30.03.2025
Job Description:
Job Description
Site Name: USA - Pennsylvania - Upper Providence, GSK HQ, Home Worker - USA, Stevenage, Waltham
Posted Date: Feb 11 2025
Clinical Statisticians are highly prized and urgently needed at GSK to grow an industry-leading team to ensure high quality quantitative reasoning is at the heart of every project in the portfolio. Our role is essential to maximize the use of every single data point available to efficiently determine translational strategies that are the foundation of our end-to-end clinical development plans. We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical methodology to drive key contributions to the development of new medicines.
The Oncology Clinical Development Statistics group has a Statistics Leader/Associate Director opportunity available to support assets within the Oncology disease area, providing statistical and strategic insight into the clinical development plan and design of end-to-end development strategies. This begins with early first in human trials, all the way through to late phase drug development. The team strives to use novel clinical trial designs and innovative statistical methodologies, including Bayesian techniques, to quantify risk across an entire program and enable smart decision making on where to invest to improve the probability of study and program success.
Key Responsibilities:
* Leading clinical development strategy of specific indication and projects
* Partner with clinical matrix team across the clinical development organization to drive the early phase and/or later phase asset development
* Design and analysis of platform/basket trial
* Collaborate with project statisticians to identify the opportunities to align and harmonize the designs and analyses for each oncology indication
* Develop knowledge in global regulatory submissions across assets and countries with different mechanism of actions in multiple indications of oncology.
* Serve as statistical expert for internal and external collaborators, investigators, consultants, and contract resources
* Lead statistical assessment in business development opportunities
* Represent GSK-Oncology Biostatistics at scientific meetings and presentations
* Influence planning and decision-making strategy over a portfolio of assets through building and maintaining effective business relationships with key functions
* Contribute to and influence the strategic direction of the asset development and regulatory submission via rigorous and robust statistical knowledge
* Ensure state-of-the-art expertise on all methodological aspects of drug development in statistics
Basic Qualifications:
* PhD in Statistics or related discipline with 4+ years of experience working as a Statistician within a CRO, Clinical Trial, or Academic setting in the Pharmaceutical Industry, or MS in Statistics or related discipline with 7+ years of experience working as a Statistician within a CRO, Clinical Trial, or Academic setting in the Pharmaceutical Industry
* Experience designing and analyzing oncology trials
* Experience implementing innovative methods, such as Adaptive Design, Machine Learning, and Trial Simulation, using SAS, R or other professional software
* Experience with the clinical development process through commercialization
Preferred Qualifications:
* Experience with oncology statistical methodologies, either emerging or implemented, to maximize program success
* Familiarity with regulatory interactions and pathways
* Track record of strong statistical contributions and accomplishments in clinical drug development, with a broad knowledge of all phases of drug development (pre-clinical; Phase I-IV).
* Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence.
* Capable of applying innovative statistical thinking.
* Self-motivated and independent worker
* Strong time management skills; able to effectively organize and manage a variety of tasks across different projects
* Excellent interpersonal and communication skills.
Why 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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