Associate Director providing statistical leadership and support for biopharmaceutical clinical studies. Collaborating with cross-functional teams to ensure data integrity and compliance in study deliverables.
Responsibilities
Represent the statistics function and provide statistical leadership in support of clinical studies or projects
Contribute to the planning and lead the delivery of the statistical components to support the analysis and reporting needs of clinical studies/projects
Conduct ad hoc and exploratory analyses to support Medical Affairs and commercial needs
Provide statistical input to study reports, regulatory documents, publications, and other internal or external data requests
Perform statistical modeling and analyses as needed
Requirements
M.S. in Statistics/Biostatistics is required, Ph.D. is preferred
Minimum 6 years of relevant experience in the biopharmaceutical industry
Hands-on experience in all tasks of a Study Statistician (at least 4 years) or Lead Statistician (at least 2 years)
Experience with late-stage drug development, regulatory submissions, registries, or Health Authority interactions is a plus
Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations
Proficiency in SAS programming to produce ad hoc tables, listings and figures
Experience with other statistical software such as R preferred
Ability to manage multiple tasks with competing timelines
Benefits
premium health
financial
work-life and well-being offerings for eligible employees and dependents
Managing Director leading agency operations at Pacific International Lines, driving market expansion and ensuring profitability. Involving financial stability, team leadership, and compliance with regulatory standards.
Director GSCM Network & Demand Center managing global supply chain activities at Bachem, an innovation - driven company specializing in peptides and oligonucleotides.
Digital Technology Director shaping digital technology support for US operations at Bachem. Driving project delivery, stable operations, and compliance in the biopharmaceutical industry.
Director of Maintenance responsible for maintenance operations at Hyundai Translead's new facility in Joliet. Leading multi - disciplinary teams and ensuring equipment reliability and safety standards.
Director AS&T role providing analytical and quality control support for mAb and ADC projects at BioNTech in Shanghai. Engage with partners and ensure regulatory compliance while supporting operational activities.
Associate Director leading global talent, career, and performance management initiatives at BioNTech. Focused on developing high - potential employees and enhancing organizational success in a multicultural context.
Director of Real Estate overseeing Trulieve's real estate portfolio strategy across retail and corporate facilities. Responsible for market analysis, lease negotiation, and compliance in a regulated environment.
Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
Associate Director overseeing global quality initiatives at Gilead, tackling public health challenges. Leading change management to improve lives through innovative strategies and collaboration.
Associate Director, Clinical Pharmacology at Gilead managing drug development in Virology and Pediatrics therapeutic areas. Leading cross - functional study teams and authoring clinical pharmacology plans.