VP, Biostatistics

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

📋 Description

• Ensure the relevance, adequacy, and accuracy of advanced statistical methods in BioCryst-sponsored clinical development projects and selected nonclinical studies.

• Supervise statistical activities related to regulatory submissions, including NDAs and BLAs.

• Guarantee that clinical data processing adheres to regulatory standards and Good Clinical Practice.

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

• Lead and oversee junior biostatistics personnel.

• Select, direct, and manage CRO and contract staff engaged in outsourced operational tasks.

• Utilize SAS, EAST, and R for on-demand data analyses and sample-size determinations.

• Engage in clinical development and product management teams.

• Represent the organization on biostatistical matters at FDA and other regulatory agency meetings.

• Define, develop, and implement organization-wide processes aimed at enhancing efficiency and productivity.

• Define, monitor, and assess relevant performance metrics.

• Author and review essential product-development documentation, including protocols, statistical analysis plans, data management plans, regulatory briefing documents, NDAs, MAAs, regulatory responses, abstracts, and manuscripts.

• Ensure the accuracy of clinical-trial data in public corporate communications and oversee their quality-audit processes.

• Rigorously communicate technical concepts to technical, regulatory, and nontechnical audiences.

⛳️ Requirements

• Ph.D. in Biostatistics or a related discipline with a minimum of 18 years of experience in the pharmaceutical industry, including 10 or more years in the design, analysis, and interpretation of clinical trials, or an equivalent combination of education and experience.

• A minimum of 5 years of experience in people management and leadership.

• Knowledge and expertise in contemporary adaptive clinical trial designs, multiplicity testing methods, real-world evidence, and quantitative decision-making.

• Experience with NDA/BLA filings and being a key contributor to multiple successful product approvals.

• Demonstrated expertise in biostatistics disciplines, practices, and procedures, including development and accountability for relevant quality management systems.

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

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

• Exceptional written and verbal communication skills.

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

• Experience interacting with global regulatory agencies.

• Formal expertise and experience in Bayesian and frequentist statistics.

• Capability to adapt to change within a high-risk environment.

🏝️ Benefits

• Equal employment opportunities regardless of age, race, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other protected class characteristics.

• Compliance with all federal, state, and local laws.