GlaxoSmithKline LLC - Principal Statistician
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Nov 21 2019
As Principal Statistician you will manage/lead/be responsible for: Provide strategic input and statistical support into drug development programs, including trial design and analysis for drug candidates, by applying Bayesian methodology to inform decision making, and by applying biostatistics principles to the analysis and interpretation of research problems; Provide statistical support and leadership in the design, conduct, analysis, and interpretation of clinical trials through use of simulations; Prepare reporting and analysis plans; Prepare statistical input for protocols, prepare reports and communicate statistical results and implications, both verbally and in writing, to R&D clinicians and scientists; Perform statistical analyses including general linear/nonlinear models and linear/nonlinear mixed models; Perform longitudinal data analysis, repeated measure analysis, categorical data analysis and nonparametric analysis; Strive to stay informed of contemporary statistical research progress applicable to drug development within GSK; Perform statistical programming and Monte Carlo simulations using SAS and R, perform sample size estimation and power calculations using software, and perform survival analysis including log rank test, Kaplan-Meier methods and proportional hazards regression; Responsible to attend and actively participate in study conduct and project team meetings; Support regulatory submission and manuscript preparation; Keep updated with regulatory guidelines for trial conduct, reporting and analyses; and Develop strong knowledge of Oncology disease area and scientific technology.
We are looking for professionals with these required skills to achieve our goals:
Ph.D. (or foreign equivalent) in Statistics, Mathematical Statistics, Bio-behavioral Health, or a related field. Experience must include 1 year in the following: Providing statistical support in the design of clinical trials through use of statistical modeling and simulations using statistical programming languages R and SAS; Applying Bayesian methodology to trial design analysis, probability of success evaluations, and optimal dose selection; Applying biostatistics principles to the analysis and interpretation of research problems; and Oncology drug development and new drug application (NDA) or supplemental new drug application (sNDA) experience, and writing statistical analysis plans, clinical trial protocols and clinical study reports. Alternatively, a Master's degree in the same fields and 4 years of experience in the above, or a Bachelor's in the same fields and 6 years of progressively responsible experience in the above is acceptable.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations
- Budgeting and cost-consciousness
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GSK is an Equal Opportunity/Affirmative Action Employer. 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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