Senior Principal Analyst, Clinical Programming

Company Overview
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.
Role Summary
The Biometrics Department is seeking an Analyst of Clinical Programming to report to Director of Clinical Programming who will support statistical programming activities across all Cerevel clinical trials while also working closely with externally managed CROs and functional service providers (FSPs).  The Analyst will contribute to the development and implementation of a highly efficient programming ecosystem to enable seamless production across internal/external sourcing models and the delivery of timely high qualityCDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables, figures, and listings. This position requires a extensive knowledge of SAS and CDISC standards, and a broad understanding of the pharmaceutical drug development process.  Strong organizational skills, innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks, as well as strong communication skills are required.

Key Responsibilities

• Work independently in executing statistical programming tasks and delivering high quality, timely results
• Exercise independent judgement in selecting methods, techniques, and evaluation criteria for obtaining results  
• Apply broad expertise and knowledge in highly complex disciplines of clinical trials, data processes, and safety and efficacy analysis generation
• Support integrated summaries (ISE/ISS), CSR, conferences/publications, ad-hoc analyses and regulatory deliverables
• Contribute to the development of standards / best practices within the Biostatistics functional area that are consistent with highest industry standards. Be recognized internally as a subject matter expert through significant contributions to the development of the functional area capabilities
• Build strong collaborations with Clinical Operations, Data Management, and Pharmacovigilance. Provide thought leadership and work on broader organization projects

Required Qualifications

• MS degree with 7+ years of experiences or BS degree with 10+ years of experiences in statistical programming in the in the CRO or Pharmaceutical Industry with mastery of SAS programming concepts across SAS/Base, SAS/STAT, SAS/Graph, SAS/IML, and SAS/SQL
• Experiences with CDISC SDTM and ADaM models and complex clinical trial data
• Strong collaboration skills – ability to work smoothly within the function and with cross-functional teams
• Strong interests in all data elements of clinical trials
• Good understanding of the roles and responsibilities of related disciplines, including Biostatistics, Clinical Operation, Clinical Data Management, and Pharmacovigilance
• Strong verbal and written communication skills - ability to clearly and effectively present information
• Familiarity with safety data and MedDRA and WHO drug coding dictionaries

Desired Qualifications

• Experience or knowledge working in the CNS therapeutic area
• Regulatory filing experiences
• Ability to program in R, Python, SQL
• Familiarity with AI/ML technologies such as regression, supervised/unsupervised machine learning

Education

• BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics 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.