Senior Scientist, Biostatistics, Clinical Safety Statistics (CSS)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our company Research Laboratories pre- and post-marketing development stages. 

Responsibilities:

• Provide statistical support for the evaluation of clinical safety at the project level.

• Interact with Safety Physicians, Safety Scientists, Clinical Trial Physicians, Regulatory, Early/Late Development Statistics, Statistical Programming, and other our company's Research Laboratories Scientists in the planning and execution of ongoing safety evaluation across pre-marketing and post-marketing development stages

• Design, develop and evaluate processes and tools for product safety evaluation, including ongoing aggregate safety evaluation

Primary activities:

• Provide statistical support to cross-functional safety teams including strategic planning and scientific reasoning activities that facilitate safety evaluation.

• Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety.

• Design, develop and apply safety evaluation methods (including enhanced graphics analyses), processes, standards and tools.

• Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) to ensure high quality safety-related deliverables

• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.

• Prepare oral or written reports to effectively communicate results of safety evaluations to the project teams

• Evaluate appropriateness of available software for planned analyses and ascertain the need for potential program development of novel statistical methodology.

• Involved in research activities for innovative statistical methods and applications in clinical safety evaluation.

Education and Minimum Requirement:

PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master’s degree with a minimum of 3 years relevant experience. 

Required Skills and Experience:

• Knowledge of statistical analysis methodologies and experimental design, particularly in meta-analysis and Bayesian methodologies. 

• Working knowledge of statistical and data processing software e.g. SAS and/or R. 

• Good oral and written communication skills. Able to work effectively with personnel with different functional background.

• Demonstrate strong interest in statistical research activities and in application of novel methods for clinical safety evaluation.   

• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience:

• An understanding of biology of disease and drug discovery and development.

• Proficiency with AI to facilitate writing (summaries, reports, manuscripts, etc.), programming, and other types of tasks.

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Required Skills:

Biostatistics, Clinical Risk Management, Clinical Safety, Clinical Trials, Product Safety, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Programming, Strategic Planning, Visual Analytics

Preferred Skills:

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