VP, Biostatistics

BioCryst Pharmaceuticals, Inc.; Massachusetts; Hybrid; USD 220,000 - 320,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. invites a seasoned Vice President of Biostatistics to lead statistical strategy acrossBioCryst-sponsored study design, analysis and regulatory interactions. The role requires managing biostatistics teams and external CROs, ensuring GCP compliance and high-quality deliverables.

The candidate will drive regulatory support, develop innovative statistical methods, and mentor staff while aligning with company objectives in rare disease research.

Qualifications

• Ph.D. in Biostatistics (or related field) with extensive pharmaceutical industry experience and leadership.
• Experience in design, analysis and interpretation of clinical trials.
• Proven NDA/BLA filing experience and regulatory interaction.
• Expertise in Bayesian and frequentist statistical methods.
• Experience with regulatory submissions and quality systems.

Responsibilities

• Oversee statistical methods for BioCryst-sponsored clinical development activities.
• Lead regulatory submissions for NDA/BLAs and contribute to regulatory strategy.
• Manage junior biostatistics staff and CRO/contract staff.
• Communicate statistical concepts to technical and regulatory audiences.
• Contribute to process improvements and efficiency in biostatistics.

Skills

Leadership

Regulatory strategy

Statistical design

Communication

Bayesian statistics

Frequentist statistics

Education

Ph.D. in Biostatistics

Tools

SAS

EAST

R

Job description

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow uson LinkedIn and Instagram.

JOB SUMMARY:

As Vice President, Biostatistics within BioCryst Pharmaceuticals, this individual is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct and analysis of BioCryst-sponsored studies. Having managerial, technical and vendor management responsibilities, this role is responsible for the appropriate use of strategic statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics. S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies that align Biostatistics responsibilities. Performance in this role relies on an extensive experience base in study design, regulatory strategy and programming, sound judgment to plan and accomplish goals, and an ability to lead and direct the work of others. A wide scope of creativity and latitude is expected.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all BioCryst-sponsored clinical development activities and selected nonclinical studies.


• Oversees statistical activities of regulatory submissions including NDA/BLAs.


• Ensures clinical data processing conformance to relevant regulatory guidelines and Good Clinical Practice.


• Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.


• Lead and manage junior biostatistics staff.


• Selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities.


• Utilizes statistical software (SAS, EAST, R) for internal ad hoc requests for data analysis, samples sizes, etc.


• Participation in clinical development/product management teams in support of organizational objectives.


• Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics.


• Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement.


• Definition, monitoring, and evaluation of relevant performance metrics.


• Author/ reviewer of relevant sections of all critical documents required to support development of Company’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts.


• Responsible and accountable for accuracy of all data included in public corporate communications of BioCryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts. Responsible for monitoring of quality audit process for those communications.


• Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor.

EXPERIENCE & QUALIFICATIONS:

• Ph.D. in Biostatistics (or related field) with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials or an equivalent combination of education and experience. At least 5 years of people management and leadership role.


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


• NDA/BLA filing experience: key contributor to multiple successful product approvals.


• Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, including development and accountability for relevant quality management systems.


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


• Takes a hands-on approach (e.g. will do analysis of him/herself when necessary).


• Excellent written and verbal communication skills.


• Proven team player with ability to work well in a collegial environment: willing to challenge the status quo.


• Experience with global regulatory agencies.


• Formal expertise and experience in Bayesian statistics as well as frequentist statistics.


• \"Small-company attitude\" that embraces change within a high-risk environment.

EQUAL OPPORTUNITY EMPLOYER / PROTECTED VETERANS / INDIVIDUALS WITH DISABILITIES:

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Passionate. Smart. Motivated. We’re all these qualities—but most importantly, we’re committed to making a difference in the lives of those living with hereditary angioedema (HAE) and other rare diseases. If you’re someone who turns challenges into triumphs and aims to achieve beyond what you think is possible, we’re waiting for you. Culture is the fabric that binds us together and makes our company a special place to work. We are powered by our people, and every employee can provide valuable input on how we can achieve our goals through a culture of accountability. Our bold thinking comes from our \"people-first\" perspective, where we are united across fronts to do the right thing for patients, without fear of failure—but with embracing the learnings gleaned from setbacks that fuel our self-awareness. We value ownership, integrity, and the ability to laugh and learn from our mistakes. We are proud of our ability to reward innovative thinking and grow from personal and professional discovery.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.