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Added 2 hours ago
HT
Director, Finance (CSM)
Husky Technologies
Bolton, ON
- Full-time
…the highest quality products and services and are looking for people with the inspiration and talent to develop with us as we pursue our ambitious growth strategy. We are a leader in…
Added 4 hours ago
BC
Quality and Patient Safety Consultant
Brant Community Healthcare System
Brantford, ON
- Full-time
…we serve with purpose, passion, and a deep commitment to the people who rely on…
Added 8 hours ago
HT
Director, Finance (CSM)
Husky Technologies
Bolton, ON
- Full-time
…the highest quality products and services and are looking for people with the inspiration and talent to develop with us as we pursue our ambitious growth strategy. We are a leader in…
Added 8 hours ago
J
Quality Assurance Analyst
JobsMedia.io
Quebec, QC
- Full-time
…applications and technological processes. Reporting to the Deputy Director of Information Technologies, you will evolve in an environment where collaboration, continuous improvement and the…
Added 10 hours ago
M
Director, Retirement Strategy
Manulife
Toronto, ON
- Full-time
…Institutional channels in North America, Asia and Europe. The Director, Retirement Strategy will help shape the growth and transformation agenda for the U.S. and Canada Retirement…
Added 13 hours ago
E
Director of Care (DOC) - Full Time (FT) - Holyrood
Extendicare
Holyrood, NL
- Full-time
As the Director of Care, you will contribute to the Extendicare purpose of Helping People Live Better, by leading a high performing team that is dedicated to ensuring all residents receive…
Added 13 hours ago
S
Child Life Specialist, Child and Youth Therapeutic Services, T7 Medical Inpatient - BC Children’s Hospital
Sanya’k̓ula
Vancouver, BC
- Full-time
The Child Life Specialist reports operationally to the Director, Professional Practice and the designated Program Leader and professionally under the practice supervision of the Practice…
Added 14 hours ago
A
Senior Compensation Partner, Sales & Marketing
Autodesk
Vancouver, BC · Greater Vancouver Metropolitan Area
- Full-time
…manual effort and improve speed and accuracy. Partner with People Analytics and People Data Services on data quality and workforce…
Added 14 hours ago
A
Senior Compensation Partner, Sales & Marketing
Autodesk
Toronto, ON · Greater Toronto Area, Canada
- Full-time
…manual effort and improve speed and accuracy. Partner with People Analytics and People Data Services on data quality and workforce…
Added 14 hours ago
HT
Director, Finance (CSM)
Husky Technologies
Bolton, ON
- Full-time
…the highest quality products and services and are looking for people with the inspiration and talent to develop with us as we pursue our ambitious growth strategy. We are a leader in…
Added 15 hours ago
Director, Digital Experience
Sobeys Capital Incorporated or a Franchise/Affiliate / ou une franchise/société affiliée
Toronto, ON
Working closely with Technology, Site Merchandising, Marketing, Loyalty, Analytics and Operations, the Director will ensure the digital storefront evolves as a strategic growth platform…
Added 16 hours ago
BC
Quality and Patient Safety Consultant
Brant Community Healthcare System
Brantford, ON
- Full-time
…we serve with purpose, passion, and a deep commitment to the people who rely on…
Added 19 hours ago
C
Sales & Operations Execution Director
Cascades
Longueuil, QC · Saint-Hubert, QC
- $150,000 to $180,000 CAD / year
- Full-time
Join MARC-ANDRE GERVAIS's team as a Sales & Operations Execution Director in Saint-Hubert and help build a more sustainable future.
Added 19 hours ago
PS
Operations Manager
Paladin Security Group Ltd
Burnaby, BC
- $85,000 to $100,000 CAD / year
- Full-time
Meets regularly with the Director of Operations to review performance, risks, staffing, financial results, service challenges and recommended improvements.
Added 19 hours ago
Asset Performance and Reliability Engineer
Public Service Delivery
Winnipeg, MB
The Manitoba government supports equitable employment practices and promotes representation of designated groups (women, Indigenous people, persons with disabilities, visible minorities).
Added 20 hours ago
J
Quality Assurance Analyst (COPY) (COPY)
JobsMedia.io
Longueuil, QC
- Full-time
…applications and technological processes. Reporting to the Deputy Director of Information Technologies, you will evolve in an environment where collaboration, continuous improvement and the…
Added 20 hours ago
ST
Director, Philanthropy
Save the Children Canada
Toronto, ON
- Full-time
…transformational impact? Save the Children Canada is looking for a Director, Philanthropy to shape and lead our philanthropy program, grow philanthropic revenue in ambitious and sustainable…
Added 20 hours ago
J
Quality Assurance Analyst (COPY)
JobsMedia.io
Laval, QC
- Full-time
…applications and technological processes. Reporting to the Deputy Director of Information Technologies, you will evolve in an environment where collaboration, continuous improvement and the…
Added 20 hours ago
J
Quality Assurance Analyst
JobsMedia.io
Quebec, QC
- Full-time
…applications and technological processes. Reporting to the Deputy Director of Information Technologies, you will evolve in an environment where collaboration, continuous improvement and the…
Added 20 hours ago
HT
Director, Finance (CSM)
Husky Technologies
Bolton, ON
- Full-time
…the highest quality products and services and are looking for people with the inspiration and talent to develop with us as we pursue our ambitious growth strategy. We are a leader in…
Added 20 hours ago
B
Human Resources Business Partner
Baycrest
Toronto, ON
- Full-time
…both strategic and operational HR outcomes to support Baycrest People Strategy. This role will support our Research & Education, Innovation, Foundation, Terraces and Corporate portfolios…
Added 20 hours ago
GO
Asset Performance and Reliability Engineer
Government of Manitoba
Winnipeg, MB
- Full-time
…promotes representation of designated groups (women, Indigenous people, persons with disabilities, visible…
Added 20 hours ago
V
Director, Strategic Insights
Vancity
Vancouver, BC
- Full-time
As the Director, Strategic Insights, you will lead the Strategic Insights team within the Analytics Centre of Excellence and oversee how the organization engages with analytics to support…
Added 20 hours ago
W
(CAN) Senior Director, Digital Strategy and Media
Walmart
Mississauga, ON
- Full-time
The Senior Director, Digital and Media is responsible for setting and leading Walmart Canada’s enterprise growth marketing strategy across online and offline media, SEO, and customer…
Added 21 hours ago
TM
Program Analyst, PGME
Toronto Metropolitan University
Toronto, ON
- Temporary
…Canada, First Nations Peoples in the United States, racialized people, Black people, persons with disabilities, women, and 2SLGBTQ+ people. Preference will be given to candidates with lived…

BioCryst Pharmaceuticals, Inc.

Exec. Director, Biostatistics

NB, Canada
Chiasson Office, NB, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Dec 5, 2026
Posting language: English
Posted: Nov 5, 2026

Original 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 us on LinkedIn and Instagram.

Job Summary

As Exec. Director, Biostatistics, this individual leads the conduct and analysis of all BioCryst-sponsored clinical studies from Phase I to Phase IV as well as selected non-clinical studies. The role requires technical expertise as well as vendor management capabilities. The individual in this role is responsible for the appropriate use of statistical thinking and methods and conformance to principles of GCP, as applicable to biostatistics and programming. S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies related to biostatistics and programming as well as outsourcing strategy, in alignment with the goals of Biostatistics & Data Science.

S/he may act as project statistician for an individual project. 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. and direct the work of others. A wide scope of creativity and latitude is expected.

Essential Duties & Responsibilities

Responsible for Biostatistics support of BioCryst-sponsored clinical studies as well as selected non-clinical studies and Biostatistics support of Medical Affairs.
Ensures the relevance and adequacy of statistical methods employed in BioCryst-sponsored clinical development activities and selected nonclinical studies.
Ensures conformance to relevant regulatory guidelines and Good Clinical Practice.
Ensures that Biostatistics effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.
Responsible for Biostatistics oversight of CRO/contract staff for performance of outsourced operational activities. Reviews and approves contracts, work orders, and invoices within grant of authority.
Act as project statistician for an individual project.
Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics.
Thinks outside of the regulatory biostatistics box (e.g. maximum learning from phase 2 experiments regardless of pre-specified SAP, experience in Phase 3b/4 design and analysis to maximize a product’s life cycle).
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 for accuracy of 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 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.
All other duties as assigned.

Experience & Qualifications

Ph.D. in Biostatistics (or related field) with at least 12 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. Deep understanding of SAS programming is sufficient to provide oversight of statistical programming and ability to program as needed. Management experience preferred.
Strong leadership and interpersonal skills.
NDA filing experience: key contributor to one or more successful product approvals.
Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, programming, and clinical data management, including development and accountability for relevant quality management systems.
Demonstrated knowledge of the clinical development process and relevant regulatory guidelines and requirements.
Experience with Data Monitoring Committees and\or study steering committees.
Takes a hands-on approach (e.g. will do analyses 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 European and Japanese regulatory agencies.
Formal expertise and experience in Bayesian statistics as well as frequentist statistics.
Experience supporting medical affairs and post-marketing studies is an added benefit.
Flexible scheduling and ability to travel internationally.
“Small-company attitude” that embraces change within a high-risk environment.
Responsiveness and ability to prioritize effectively.

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.

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.

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More about this job

Responsibilities

Lead biostatistics support, design, analysis, and regulatory strategy for company-sponsored clinical studies from Phase I through Phase IV and selected nonclinical studies. Oversee outsourced work, contribute to regulatory submissions and communications, and improve processes, technologies, and performance across biostatistics and programming.

Requirements

Requires a Ph.D. in Biostatistics or a related field and at least 12 years of pharmaceutical industry experience, including substantial clinical trial design, analysis, and interpretation experience. Candidates should bring deep SAS and regulatory expertise, successful NDA filing contributions, leadership and communication skills, and experience with Bayesian and frequentist methods.

Skills

Biostatistics
Clinical Trial Design
Statistical Analysis
SAS Programming
Regulatory Strategy
Clinical Development
Good Clinical Practice
Vendor Management
Statistical Programming Oversight
Bayesian Statistics
Frequentist Statistics
Regulatory Submissions
Data Monitoring Committees
Quality Management Systems
Leadership
Scientific Communication

Visa sponsorship

Not detected in the job text

Keywords

Biostatistics
Clinical Trials
Phase I
Phase II
Phase III
Phase IV
Nonclinical Studies
SAS
Statistical Programming
Clinical Data Management
Good Clinical Practice
Regulatory Guidelines
Study Design
Statistical Analysis Plans
Data Management Plans
NDA
MAA
FDA
Data Monitoring Committees
Study Steering Committees
Bayesian Statistics
Frequentist Statistics
Medical Affairs
Post-Marketing Studies
CRO Oversight
Quality Management Systems
Performance Metrics
Outsourcing Strategy
Regulatory Submissions
Clinical Development

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