Associate Director, Oncology Statistics Clinical Development

GlaxoSmithKline
London
1 month ago
Applications closed

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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 ensure we 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 OncologyClinical Development Statisticsgroup has aStatistics Leader/Associate Directoropportunity 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 strive 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
  • Developing 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 the 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.

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