Senior Manager, Biostatistics

Braeburn

Senior Manager of Biostatistics at Braeburn collaborating on statistical analyses for clinical trials and RWE initiatives. Driving high-quality statistical support and contributions to regulatory submissions and study design.

Posted 6/25/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Works collaboratively with internal and external teams (e.g., CROs, medical communications vendors, and external research partners) to coordinate the planning and execution of statistical deliverables related to clinical trials and RWE initiatives.
Plans, specifies, and performs statistical analyses for publications, including manuscripts, posters, and oral presentations.
Supports clinical trials as a study statistician, providing high-quality statistical support.
Contributes to interventional, observational, post-marketing, and RWE study design, and protocol development, including authoring the Statistics section in protocols and working cross-functionally on overall study design.
Authors SAPs for clinical trials, and develops shells for tables, figures, and listings.
Reviews CRF designs to ensure data collection supports the statistical analyses for primary, secondary, and exploratory endpoints.
Performs QC/QA of statistical deliverables, including validation of key analysis results.
Contributes to CSRs, including authoring statistical methods and interpreting study results.
Supports statistical activities for IND/NDA/MAA and other regulatory submissions and helps address statistical questions from FDA and other regulatory agencies.
Contributes to standardization and process improvement efforts for Biostatistics and to cross-functional process improvement.
Evaluates and, where appropriate, integrates AI tools to enhance the efficiency and quality of statistical activities.

Requirements

What you’ll need

Master’s or Ph.D. in Biostatistics or closely related field
At least 4 years of experience in biostatistics or related roles in the pharmaceutical or biotech industry
Advanced computer and internet skills, including knowledge of MS applications (such as Word, PowerPoint, Teams, Excel), SharePoint
Hands-on clinical trials experience, including authoring SAPs, reviewing SDTM and ADaM datasets and TLFs, and contributing to CSRs.
Experience with real-world evidence, health economics, and outcomes research is preferred.
Experience supporting FDA submissions (e.g., IND/NDA) is preferred.

Benefits

Comp & perks

Health insurance
Remote work options

ATS Keywords

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Hard Skills & Tools

biostatisticsstatistical analysesclinical trialsstudy designSAP authoringQC/QAstatistical methodsdata collectionreal-world evidencehealth economics

Soft Skills

collaborationcommunicationcross-functional teamworkprocess improvementattention to detailproblem-solvingorganizational skillsanalytical thinkinginterpersonal skillsadaptability

Certifications

Master’s in BiostatisticsPh.D. in Biostatistics