Executive Director, Biometrics

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Lead the execution and evaluation of BioCryst-sponsored clinical studies from Phase I through Phase IV, along with selected non-clinical studies.

• Provide Biometrics support for clinical studies, select non-clinical studies, and Medical Affairs.

• Ensure the applicability and sufficiency of statistical methods while adhering to regulatory standards and Good Clinical Practice.

• Contribute to clinical development strategies, program development, and study design.

• Supervise CRO and contract personnel engaged in outsourced operational tasks.

• Review and authorize contracts, work orders, and invoices within the scope of delegated authority.

• Serve as the project statistician for individual projects.

• Represent the company as the biostatistical spokesperson in meetings with the FDA and other regulatory bodies.

• Define, establish, and execute organization-wide processes aimed at enhancing efficiency and productivity.

• Define, track, and assess relevant performance metrics.

• Author and review statistical and biometrics sections of protocols, statistical analysis plans, data management plans, regulatory documents, NDAs, MAAs, regulatory responses, abstracts, and manuscripts.

• Ensure the precision of clinical trial data in public corporate communications, including press releases, presentations, SEC filings, abstracts, and manuscripts.

• Oversee the quality audit process for public communications regarding clinical trials.

• Convey technical concepts to technical, regulatory, and broader non-technical audiences.

• Identify, assess, and implement innovative biostatistics and programming processes and technologies.

• Develop and align outsourcing strategies with Clinical Development objectives.

• Perform additional duties as assigned.

⛳️ Requirements

• Ph.D. in Biostatistics or a related field with a minimum of 12 years of experience in the pharmaceutical industry, including at least 10 years in the design, analysis, and interpretation of clinical trials, or an equivalent combination of education and experience.

• Profound understanding of SAS programming, sufficient to oversee statistical programming and perform programming tasks as needed.

• Strong leadership and interpersonal abilities.

• Experience with NDA filings as a key contributor to one or more successful product approvals.

• Proven proficiency in biostatistics, programming, and clinical data management, including development and accountability for relevant quality management systems.

• Demonstrated knowledge of the clinical development process and pertinent regulatory guidelines and requirements.

• Experience with Data Monitoring Committees and/or study steering committees.

• Hands-on approach, including performing analyses when necessary.

• Excellent written and verbal communication skills.

• Ability to thrive in a collegial environment and challenge the status quo.

• Experience working with European and Japanese regulatory agencies.

• Formal expertise and experience in both Bayesian and frequentist statistics.

• Flexible scheduling and willingness to travel internationally.

• Responsiveness and effective prioritization skills.

🏝️ Benefits

• Equal employment opportunity protections.

• Protections for Protected Veterans/Individuals with Disabilities status.

• Flexible scheduling options.

• Opportunity to work on innovative first-in-class or best-in-class therapeutics.

• International travel opportunities.