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Added 11 mins ago
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Senior Manager, T&O M&A, Strategic Initiatives
BMO
Toronto, ON · FCP
- Full-time
The Senior Manager, M&A Technology & Operations, operates across senior executives, technology teams, business partners and external advisors and requires strong program leadership,…
Added 11 mins ago
F
Manager, Information Security Risk
FCT
Oakville, ON
- Full-time
As the Manager, Information Security Risk, you will lead the assessment, governance, and oversight of information security risks across enterprise technology initiatives, with a primary…
Added 41 mins ago
BP
Corporate Communications Content Manager
BioCryst Pharmaceuticals, Inc.
NB · Chiasson Office, NB
- Full-time
Reporting to the Vice President, Corporate Communications, the Corporate Communications Content Manager serves as a central content creator and communications partner across BioCryst's…
Added 41 mins ago
BP
VP, Biostatistics
BioCryst Pharmaceuticals, Inc.
NB · Chiasson Office, NB
- Full-time
…BioCryst-sponsored studies. Having managerial, technical and vendor management responsibilities, this role is responsible for the appropriate use of strategic statistical thinking and…
Added 41 mins ago
BP
Exec. Director, Biostatistics
BioCryst Pharmaceuticals, Inc.
NB · Chiasson Office, NB
- Full-time
…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…
Added 41 mins ago
TT
EHSS Intern- Summer 2027
TTM Technologies
Toronto, ON
- Full-time
Must be returning to the final year of a relevant postsecondary program in September 2027, with expected graduation no later than June 2028.
Added 41 mins ago
TT
Process Engineering Intern - Dry Process - Summer 2027
TTM Technologies
Toronto, ON
- Full-time
Must be returning to the final year of a relevant postsecondary program in September 2027, with expected graduation no later than June 2028.
Added 41 mins ago
TT
Operations Engineering Intern - Summer 2027
TTM Technologies
Toronto, ON
- Full-time
Mentor: Director of Operations & Sr Inside Sales Manager
Added 41 mins ago
TT
Process Engineering Intern - Wet Process Summer 2027
TTM Technologies
Toronto, ON
- Full-time
Must be returning to the final year of a relevant postsecondary program in September 2027, with expected graduation no later than June 2028.
Added 41 mins ago
C
Project Manager - Learning and Development
Cella
Toronto, ON
- $63 to $68 CAD / hour
- Contract
As a Project Manager within HR Learning & Development, you will direct end-to-end project lifecycles for critical enterprise learning initiatives. You will act as the central driver for…
Added 41 mins ago
G
Manager, Global Benefits
Geotab
Toronto, ON
- Full-time
…objectives, integrating AI and data-driven tools to modernize program delivery, and supporting organizational growth through M&A activity. The Global Benefits Manager leads a team of…
Added 41 mins ago
G
Manager, Global Benefits
Geotab
Waterloo, ON
- Full-time
…objectives, integrating AI and data-driven tools to modernize program delivery, and supporting organizational growth through M&A activity. The Global Benefits Manager leads a team of…
Added 41 mins ago
G
Manager, Global Benefits
Geotab
Oakville, ON
- Full-time
…objectives, integrating AI and data-driven tools to modernize program delivery, and supporting organizational growth through M&A activity. The Global Benefits Manager leads a team of…
Added 41 mins ago
KR
Information Technology Manager
KeepRite Refrigeration
Brantford, ON
- Full-time
We are currently seeking an IT Manager to lead our IT team. This role is responsible for maintaining all computer hardware and software, as well as our other information systems. This…
Added 1 hour ago
P
Spécialiste bilingue des applications cliniques - Surveillance des patients en milieu hospitalier (poste sur le terrain au Québec)
Philips
Montreal, QC
- Full-time
Added 1 hour ago
F
Manager, Information Security Risk
FCT
Oakville, ON
- Full-time
As the Manager, Information Security Risk, you will lead the assessment, governance, and oversight of information security risks across enterprise technology initiatives, with a primary…
Added 1 hour ago
TT
EHSS Intern- Summer 2027
TTM Technologies
Toronto, ON
- Full-time
· Must be returning to the final year of a relevant postsecondary program in September 2027, with expected graduation no later than June 2028.
Added 1 hour ago
TT
Operations Engineering Intern - Summer 2027
TTM Technologies
Toronto, ON
- Full-time
Mentor: Director of Operations & Sr Inside Sales Manager
Added 1 hour ago
TT
Process Engineering Intern - Wet Process Summer 2027
TTM Technologies
Toronto, ON
- Full-time
· Must be returning to the final year of a relevant postsecondary program in September 2027, with expected graduation no later than June 2028.
Added 1 hour ago
TT
Process Engineering Intern - Dry Process - Summer 2027
TTM Technologies
Toronto, ON
- Full-time
· Must be returning to the final year of a relevant postsecondary program in September 2027, with expected graduation no later than June 2028.
Added 1 hour ago
TJ
Manager, Fixed Operations
The Jim Pattison Auto Group
North Vancouver, BC
- Full-time
We are seeking an experienced, results-driven Fixed Operations Manager to lead, direct, and grow our Parts and Service departments. This executive leadership role is responsible for the…
Added 1 hour ago
V
Maintenance & Project Manager
Veolia
Pickering, ON
- Full-time
The Maintenance and Project Manager plays a key role within the maintenance team, ensuring the coordination and smooth execution of daily and periodic maintenance activities across the…
Added 1 hour ago
LM
DIRECTOR OF INFORMATION TECHNOLOGY
Lacroix Médecine Privée
Quebec, QC
- Full-time
We are looking for an experienced manager with a strong business acumen and excellent technological expertise, recognized for their leadership, judgment, and ability to drive organizational…
Added 1 hour ago
GT
Project Manager
Global Technical Talent, an Inc. 5000 Company
Toronto, ON
- Contract
…mid-to-high complexity L&D training initiatives. The Project Manager will develop an understanding of the overall portfolio and program movement with individual lines of business,…
Added 1 hour ago
G
Manager, Global Benefits
Geotab
Waterloo, ON
- Full-time
…objectives, integrating AI and data-driven tools to modernize program delivery, and supporting organizational growth through M&A activity. The Global Benefits Manager leads a team of…

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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