Posted 31 Jan 2024, 6:00 am
Senior Manager Biostatistics at Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
The Biometrics Department is seeking a Senior Manager of Biostatistics, reporting to the Head of Biostatistics, who will implement statistical strategy to optimally support drug development across Cerevel clinical programs. The Senior Manager will collaborate with R&D functions to develop comprehensive statistical analysis plans and lead the delivery of high-quality study data analysis results. This position requires attentions to details, hands-on execution capabilities, strong organizational skills, agility to respond promptly and completely to time-critical tasks, as well as strong communication skills.\n
- Serve as the lead statistician across multiple clinical studies and, in collaboration with key stakeholders, ensure the scientific, regulatory, and quality rigor of the studies
- Take accountability of Biostatistics deliverables at the study level, including planning and tracking study level activities, providing oversight of CROs, developing SAPs, and conducting exploratory data analyses
- Keep abreast emerging statistical method development and related regulatory requirements; provide sound statistical underpinning of clinical study design, analysis and reporting
- Contribute/lead the development of standards / best practices within the Biostatistics functional area in accordance with internal and industry standards to increase efficiency and minimize risks
- Build strong collaborations with Clinical Development and Operations, Data Management, Statistical Programming and Pharmacovigilance
- PhD in Biostatistics/Statistics or equivalent with 4+ years relevant experience or MS in Biostatistics/Statistics with 6+ years relevant experience
- Thorough understanding of clinical trial process and proven knowledge and expertise in statistics and its applications to clinical trials
- Fluency in statistical software (including SAS and R)
- Deep hands-on operational experiences in Biostatistics deliverables at study level, including study design, protocol development, CRFs and clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings
- Understanding of relevant regulatory guidance
- Ability to develop innovative/creative statistical/technical solutions to problems
- Leadership skills in priority evaluations, project management, conflicts resolutions, and effective partnership
- Strong verbal and written communication skills. able to explain statistical methodology, study results, and consequences of decisions in lay terms
- Innovative, flexible mindset with ability to adapt to changes
- Past clinical trial experiences across different drug development phases
- Experience or knowledge working in ISS and ISE
- Familiarity with outsourcing models
- PhD or MS in Statistics/Biostatistics or related area
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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Source: Remote Ok