Associate Principal Biostatistician, Clinical Safety Statistics (CSS), Hybrid

Job Description

The Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional group in our company's Research Laboratories. Since its establishment in 1938, this department has provided 85+ years of quantitative leadership in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D.  The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development Division pre- and post-marketing development stages. 

Key responsibilities for the position:

• Serve as a statistical representative and core member in the Risk Management Safety Teams.  Lead and provide statistical support for related drug/vaccine projects in Clinical Safety Statistics

• Interact with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, Statistical Programming, , and other company 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 for the position:

• Lead and provide statistical support to the cross-functional safety teams for the strategic planning and scientific reasoning that facilitates safety and benefit-risk evaluations

• Plan and execute on  aggregate safety evaluations, including cumulative meta-analysis of safety, as applicable. Coordinate and ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements

• Design, develop and apply safety evaluation methods (including visual analytics), processes, standards and tools

• Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) to strategize and plan high quality integrated safety analyses for NDA submission and periodic risk-benefit evaluation

• Interact with regulatory agencies worldwide to engage on statistical issues associated with the ongoing aggregate review of safety. 

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

• Mentor and guide junior staff in functional activities.

Skills

Education and Minimum Requirement:

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or Masters with a minimum of 6 years relevant work experience.

Required Skills and Experience:

• Solid knowledge of statistical analysis methodologies and experimental design, particularly in meta-analysis and bayesian methodologies.

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

• Good project management skills.   

• Good understanding of worldwide regulatory requirements and clinical trial expertise .

• Strong oral and written communication skills. Able to function effectively in a team environment.  

• 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:

• Publications in peer reviewed statistical/medical journals. 

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

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