Senior Scientist, Biostatistics, Clinical Safety Statistics (CSS)

About this role

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.
• BARDS2020
• #EligibleforERP
• 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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• Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a
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