Principal Biostatistician, Clinical Safety Statistics (CSS)

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 multiple Risk Management Safety Teams

• Lead, coordinate, and provide biostatistical support for related drug/vaccine projects in Clinical Safety Statistics

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

• Lead the design, development and evaluation of processes and tools for product safety evaluation, including ongoing aggregate safety evaluation 

Primary activities for the position:

• Serve as statistical lead in 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. May take a team leadership role to coordinate and ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements

• Take a lead role in the design, development and application of safety evaluation methods (including visual analytics), process, standard and tools

• Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) staff to ensure high quality safety-related regulatory deliverables for NDA submission and periodic risk-benefit evaluation

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

• May represent Clinical Safety Statistics on company initiatives

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

• Mentor and guide junior staff in functional activities. May provide project oversight of junior staff, as appropriate.

Education and Minimum Requirement: 

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or Masters with a minimum of 9 years relevant work experience.

Required Skills and Experience:

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

• Strong project management skills.   

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

• Thorough understanding of worldwide regulatory requirements and broad clinical trial expertise from phase I to V. 

• 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 to clinical safety evaluation

• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focused 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.

NOTICE FOR INTERNAL APPLICANTS

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