Senior Manager, Biostatistics

About the Company

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.

Responsibilities

• Coordinate the planning and execution of statistical deliverables related to clinical trials and RWE initiatives with internal and external teams
• Plan, specify, and perform statistical analyses for publications, including manuscripts, posters, and oral presentations
• Support clinical trials as a study statistician
• Contribute to interventional, observational, post-marketing, and RWE study design and protocol development
• Author SAPs for clinical trials and develop shells for tables, figures, and listings
• Review CRF designs to ensure data collection supports statistical analyses
• Perform QC/QA of statistical deliverables and validate key analysis results
• Contribute to CSRs by authoring statistical methods and interpreting results
• Support statistical activities for IND/NDA/MAA and other regulatory submissions
• Evaluate and integrate AI tools to enhance statistical activity efficiency

Requirements

• Master’s or Ph.D. in Biostatistics or a closely related field
• At least 4 years of experience in biostatistics within the pharmaceutical or biotech industry
• Hands-on clinical trials experience including authoring SAPs and reviewing SDTM/ADaM datasets
• Proficiency in SAS or R
• Strong understanding of CDISC, SDTM, and ADaM data standards
• Working knowledge of FDA, EMA, and ICH regulations
• Ability to travel up to 15%