Associate Director, Biostatistics

Reports to: Senior Director of Medical Affairs

Location: Plymouth Meeting, PA (Hybrid) or 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 Associate Director of Biostatistics will be working with a cross functional team as the biostatistician responsible for all statistical activities related to Medical Affairs, Clinical Development, and HEOR tactics. This individual must be a good communicator, creative, high-energy, self-motivated, and forward thinking. 

Specific Duties:

• Performs all statistical analyses for the preparation of publications, including manuscripts, posters and oral presentations, and contributes to their publication as an author or key stakeholder.
• Serves as study statistician for clinical trials and provides high quality decision support.
• Contributes to interventional, observational, post-marketing, and RWE study design and protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.
• Works collaboratively with internal and external (e.g., CRO, medical communications vendors) team members to coordinate the planning and execution of statistical deliverables.
• Conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs.
• Authors statistical analysis plans (SAPs) for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and develops shells for tables, figures and listings.
• Reviews case report form (CRF) designs to ensure data collection will provide the necessary data to perform all statistical analyses for primary, secondary, and exploratory endpoints.
• Designs and specifies randomization schedules; reviews and approves test randomization lists.
• Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents.
• Programs or reviews analysis dataset specifications.
• Performs QC/QA of statistical deliverables including validation of key analysis results.
• Performs ad hoc, post hoc, and exploratory statistical analyses.
• Contributes to clinical study reports (CSRs), including authoring of statistical methods and interpretation of the study results.
• Leads statistical activities in support of IND/NDA/MAA or other regulatory submissions.
• Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs.
• Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.
• Authors biostatistics SOPs and contributes to the development of SOPs for related activities.

Skills:

• Strong written and oral communication and collaboration skills. Ability to communicate concepts clearly and concisely verbally and in written form to broad audiences inside and outside the clinical team
• Must be well organized and able to multi-task in a fast-paced deadline-driven environment
• Demonstrated ability to work independently
• Skilled in preparing graphical data displays
• Demonstrated ability and experience in the design and analysis of clinical trials, and the reporting and publication of clinical trial results
• In-depth knowledge of statistical methods for clinical trials
• Experience in regulatory submissions desirable, but not required
• Working knowledge of FDA, EMA and ICH regulations and guidelines
• Understanding of data standards, including CDISC, SDTM, and ADaM
• Ability to work closely with CROs to ensure effective collaboration to enable efficient provision of statistical outputs throughout study lifecycle
• Ability to collaborate effectively with colleagues from other functions
• Awareness of current developments in Real World Evidence methodologies
• Understanding of innovative and adaptive clinical trial designs and opportunities to utilize them to improve clinical trial execution and efficiency

Education/Experience:

• Ph.D. in Statistics/Biostatistics or related discipline. Masters considered based upon experience.
• At least 7 years of experience in biostatics 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
• Proficient in statistical programming, coding, and design/sample size software (e.g. SAS)
• Proven experience with working in a hybrid or remote environment
• Experience with real-world evidence, health economics, and outcomes research 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.