Senior Manager, Biostatistics

Reports to: Associate Director, Biostatistics

Location: Remote 

Company Overview:

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.

At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential.

Position Summary:

The Senior Manager of Biostatistics works cross-functionally to identify, specify, perform, and disseminate statistical analyses in support of Braeburn’s evidence generation activities and regulatory requirements. The ideal candidate pairs statistical aptitude with strong communication, creativity, and forward thinking.

Specific Duties:

• 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.

Skills:

• Strong written and oral communication and collaboration skills, with the ability to convey concepts clearly and concisely to broad audiences inside and outside the clinical team.
• Well organized and able to multi-task in a fast-paced, deadline-driven environment, working both independently and collaboratively across functions.
• Skilled in the design and analysis of clinical trials and in reporting and publishing results, with in-depth knowledge of statistical methods for clinical trials.
• Proficiency in statistical software (e.g., SAS, R), including preparing publication-ready figures.
• Working knowledge of FDA, EMA, and ICH regulations and guidelines.
• Strong understanding of data standards, including CDISC, SDTM, and ADaM.
• Ability to travel (up to 15%).

Education/Experience: 

• 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.

Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, "Protected Categories"). In fact, we encourage all underrepresented backgrounds to apply for any open job positions with the company.

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