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Added 7 mins ago
RC
Marketing Manager, Customer Execution
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Mississauga, ON
- $95,000 to $115,000 CAD / year
Reporting to the Sr. Director, Marketing, the Marketing Manager, Customer Execution, recommends and leads marketing activations and ecommerce performance across key retailers and…
Added 7 mins ago
Senior Electrical Engineer Power Electronics
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NS · Bedford, Nova
Reporting to the Manager, Hardware Engineering, the Senior Hardware Engineer (Power Electronics) will contribute to the design, development, integration, and verification of…
Added 7 mins ago
SA
Manager, Customer Success
Schema App
Remote, Canada
- $120,000 to $130,000 CAD / year
- Full-time
- Remote
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Added 21 mins ago
Senior Manager, Analytics & Insights
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Added 21 mins ago
Senior Manager, Analytics Engineering
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Added 21 mins ago
JI
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Opportunities to take part in job-related training and development
Added 21 mins ago
R
Marketing Manager, Customer Execution
Revlon
Toronto, ON
- $95,000 to $115,000 CAD / year
- Full-time
Reporting to the Sr. Director, Marketing, the Marketing Manager, Customer Execution, recommends and leads marketing activations and ecommerce performance across key retailers and…
Added 21 mins ago
R
Marketing Manager, Customer Execution
Revlon
Mississauga, ON
- $95,000 to $115,000 CAD / year
- Full-time
Reporting to the Sr. Director, Marketing, the Marketing Manager, Customer Execution, recommends and leads marketing activations and ecommerce performance across key retailers and…
Added 36 mins ago
SE
Manager, Digital Product
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Mississauga, ON
- Full-time
We are seeking a creative and talented Digital Product Manager with Mobile App & UX/UI design experience who will work across multiple teams to design, plan, implement, & continuously…
Added 36 mins ago
P
Group Product Manager
Priceline
Toronto, ON
- Full-time
…they find a great deal with us or keep shopping. As the Group Product Manager for Search, you will own that front door from end to end, across hotels, flights, rental cars, and…
Added 36 mins ago
SC
Acquisition Account Manager - French Bilingual Hybrid
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- Full-time
As an Acquisition Account Manager supporting SPP Canada, you will build a high-value new business pipeline and turn promising opportunities into lasting client partnerships. You will work…
Added 36 mins ago
T
Manager, Business Systems Analysis, TD Securities
TD
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- Full-time
…opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been…
Added 51 mins ago
TC
Finance Manager
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Mississauga, ON
- $100,000 to $120,000 CAD / year
- Full-time
Develop financial business cases for new product launches, product extensions, and SKU rationalization initiatives.
Added 51 mins ago
M
Sr. Marketing Manager, Core Surgical Innovations
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- Full-time
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Added 51 mins ago
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Project/Technical Buyer
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…technical engagement with other leading companies, we create new products and market-driven solutions that expand customer capabilities while growing our…
Added 51 mins ago
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Sr. NPI Supply Chain Program Manager
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Lead NPI supply chain program planning and execution of deliverables for a given product, technology development and/or key component. This includes project planning, schedule / status…
Added 51 mins ago
Business Development Manager, Advanced Integrity Division
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Calgary, AB
ROSEN is looking for a Business Development Manager, that will be based in Houston, TX. This position reports directly to the Vice President, Advanced Integrity Division and will be a part…
Added 1 hour ago
FB
Operations Manager, Virtual Services
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The Operations Manager, Virtual Services leads the Company's virtual service delivery model. The role oversees the people, processes, and tools that power virtual service across all…
Added 1 hour ago
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Added 1 hour ago
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Assistant Department Manager - Collingwood
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Added 1 hour ago
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Added 1 hour ago
BP
VP, Biostatistics
BioCryst Pharmaceuticals, Inc.
NB · Chiasson Office, NB
- Full-time
Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.
Added 1 hour ago
UL
Manager, Professional Resources & Legal Support
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Added 1 hour ago
BP
Exec. Director, Biostatistics
BioCryst Pharmaceuticals, Inc.
NB · Chiasson Office, NB
- Full-time
Ensures that Biostatistics effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.
Added 1 hour ago
TT
EHSS Intern- Summer 2027
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…services enable customers to reduce the time required to develop new products and bring them to…

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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