Senior Manager, Biostatistics

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Braeburn

WebsiteLinkedInAll Job Openings

11 - 50 employees

⚕️ Healthcare Insurance

🤝 Non-profit

💊 Pharmaceuticals

💰 $110M Debt Financing on 2018-01

Healthcare Insurance • Non-profit • Pharmaceuticals

Braeburn is a company committed to transforming the management of opioid use disorder. With a strong focus on eliminating stigma and improving access to treatment, Braeburn partners with various organizations to volunteer and advocate for health equity. Their initiatives include community support programs, educational docuseries, and a national bus tour aimed at mobilizing recovery efforts across America. Braeburn's holistic approach emphasizes the importance of community support and harm reduction strategies to address the opioid crisis.

📋 Description

• 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

• 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

• Health insurance • Remote work options