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Added 11 mins ago
J
Jr Aquatic Biologist
Jacobs
Calgary, AB
- $49,800 to $75,350 CAD / year
- Full-time
…natural resources. As an aquatic biologist, you will provide technical support on the aquatic biology and water resource permitting components of our challenging natural resource projects.…
Added 11 mins ago
J
Jr Aquatic Biologist
Jacobs
Prince George, BC
- $49,800 to $75,350 CAD / year
- Full-time
…natural resources. As an aquatic biologist, you will provide technical support on the aquatic biology and water resource permitting components of our challenging natural resource projects.…
Added 11 mins ago
J
Jr Aquatic Biologist
Jacobs
Burnaby, BC
- $49,800 to $75,350 CAD / year
- Full-time
…natural resources. As an aquatic biologist, you will provide technical support on the aquatic biology and water resource permitting components of our challenging natural resource projects.…
Added 11 mins ago
AA
Chef de projet entrée en service / Entry Into Service Project Manager
Airbus Aircraft
Montreal, QC
- Full-time
Transférez le compte au directeur du support client par le biais d'un transfert de projet propre et d'un support pendant une période de transition convenue.
Added 11 mins ago
LD
Senior Electrical Engineer Power Electronics
Leonardo DRS
Bedford, NS
- Full-time
…and trade studies through prototype bring-up, qualification support, and transition to production. The successful candidate will provide hands-on technical guidance to developing engineers…
Added 11 mins ago
TP
Senior Electrical Engineer A
Tetra Pak
Toronto, ON
- $110,800 to $158,200 CAD / year
- Full-time
Provide technical electrical support both internally and towards customers.
Added 11 mins ago
K
Project Engineer
Kiewit
Calgary, AB
- Full-time
The Project Engineer will support construction activities by planning, organizing and implementing those management duties (i.e. engineering interface, subcontract and materials management,…
Added 11 mins ago
TP
Senior Automation Engineer A
Tetra Pak
Toronto, ON
- $110,800 to $158,200 CAD / year
- Full-time
Bachelor’s degree in electrical engineering/Automation Engineering or related technical field.
Added 11 mins ago
TU
Research Associate
The University of British Columbia
Vancouver, BC
- Full-time
A PhD in a relevant scientific discipline, with a minimum of three years of postdoctoral experience in RNA therapeutics, drug delivery, nanomedicine, or a related field.
Added 11 mins ago
M
H&B Consultant
Marsh
Montreal, QC
- Full-time
…candidate will also coach less experienced COE analysts, provide technical peer review, support project coordination, and contribute to the ongoing improvement of tools, templates, and…
Added 11 mins ago
WE
Project Manager
West End Workforce
AB · Edmonton, AB
- Full-time
These are field roles. The site leadership is hiring builders: project managers who walk the work every day and sort out problems on the spot with their contractors.
Added 11 mins ago
K
Project Engineer
Kiewit
AB · Edmonton, AB
- Full-time
The Project Engineer will support construction activities by planning, organizing and implementing those management duties (i.e. engineering interface, subcontract and materials management,…
Added 12 mins ago
T
Trade Compliance Manager
Thales
Ottawa, ON · Montreal, QC
- Full-time
Requires direct or indirect access to hardware, software, technology or technical data controlled under the Canadian Export Control List, the ITAR or the EAR.
Added 12 mins ago
H
Field Service Representative
Hitachi
Kelowna, BC · (HE)Office_BC_Kelowna NEW
- Full-time
…troubleshooting practices, you will help maintain system reliability and support the continuous operation of critical infrastructure. This role offers variety, autonomy, and opportunities…
Added 12 mins ago
TI
Technical Product Owner
Tecsys Inc.
Remote, Canada
- Remote
As a Technical Product Owner, you will join our Itopia platform team, a team at the heart of the low-code application platform that Tecsys Elite is built on. Itopia powers our warehouse,…
Added 12 mins ago
E
Territory Representative, Hospitality Sales & Service
Ecolab
Mississauga, ON · Richmond Hill, ON · Toronto, ON · Woodbridge, ON · ON
- Full-time
Added 27 mins ago
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Forward Deployment Engineer
''
Toronto, ON
- Full-time
The Forward Deployment Engineer works as the single accountable owner for an AI use case while partnering with a technical lead and a dedicated cross-functional pod. The pod may include AI…
Added 27 mins ago
'
Associate Cloud Engineer
''
Florenceville-Bristol, NB
- Full-time
Respond to alerts and incidents, troubleshoot technical issues, and support root cause analysis.
Added 27 mins ago
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Master Data Management Engineer
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Toronto, ON
- Full-time
McCain is seeking an MDM Technical Process Engineer, Product and Material, to support our global data governance and digital transformation priorities. In this role, you will help govern…
Added 41 mins ago
PE
Structural Engineer
PTW Energy Services
Calgary, AB
- Full-time
As a Structural Engineer, you'll take ownership of projects from concept through fabrication and field support, delivering safe, practical, and cost-effective structural solutions while…
Added 41 mins ago
PE
Structural EIT
PRI Engineering
Calgary, AB
- Full-time
Hands-on exposure to structural design, drafting, and construction support across PRI's building, institutional, industrial, and resource-sector projects - nationwide
Added 41 mins ago
Y
Field Service Engineer I
Yokogawa
NB · Chiasson Office, NB
- Full-time
Assist with compiling and maintaining project databases, system configuration data, and technical documentation under the guidance of experienced engineers.
Added 41 mins ago
PE
Intermediate Structural Engineer
PRI Engineering
Calgary, AB
- Full-time
This is a hands-on technical role for a structural engineer who is comfortable carrying a design from concept through construction documents and into the field. You will develop structural…
Added 41 mins ago
C
Staff Technical Program Manager, Data Center New Product Introduction
Cerebras
Canada
- Full-time
Cerebras is seeking a Staff Technical Program Manager to lead Data Center New Product Introduction (NPI), preparing new AI systems and infrastructure designs for reliable deployment at…
Added 41 mins ago
SE
Supplier Quality Engineer
Siemens Energy
Oakville, ON
- Full-time
Supplier Qualification: Support a cross-functional team by assessing supplier capabilities, auditing supplier quality management systems & processes.

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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