Biostatistician

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven compassionate and laser focused on making a dramatic positive impact with everything we undertake.

When you join API you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries increasing the amount of commercial research and development in the country and supporting Alberta as a key pillar in Canadas life sciences sector.

The Biostatistician provides statistical expertise for biotech sponsors and academic investigators across clinical and translational research. Key responsibilities include supporting study designsuch as endpoint selection sample size and power calculations and randomization or interim analysis strategiesand developing or reviewing statistical analysis plans. The role conducts or oversees data analyses using rigorous appropriate methodologies and communicates findings clearly in protocols reports manuscripts and regulatory or grant submissions.

The Biostatistician collaborates closely with clinicians scientists data managers and programmers to ensure studies generate reliable interpretable evidence. They also contribute to grant applications by preparing statistical sections design justifications and analytic plans and offer ongoing statistical support from study startup through final analysis and dissemination.

** Please note this position requires full-time on-site presence.

Key Responsibilities include but are not limited to:

Study Design & Strategy

• Lead Design: Lead the design and analysis of studies including protocol review and sample size estimation.
• Methodology: Select and justify appropriate statistical methods to ensure rigorous scientific and clinical outcomes.
• Strategic Oversight: Ensure statistical integrity across multiple concurrent projects and provide expert guidance on data validity.

Statistical Analysis & Programming

• Plan Development: Develop and assist with Statistical Analysis Plans (SAPs) ranging from simpler studies to more complex designs.
• Execution: Perform data cleaning quality control (QC) and routine to advanced statistical programming (e.g. R or SAS).
• Standards Compliance: Apply CDISC standards (SDTM/ADaM) to ensure data is submission-ready for biotech regulatory filings.
• Interpretation: Conduct analyses and interpret results within their specific scientific and clinical contexts.

Collaboration & Reporting

• Project Ownership: Own the statistical lifecycle for clinical studies interfacing directly with investigators.
• Cross-functional Teamwork: Collaborate closely with data managers clinicians and programmers to ensure seamless project execution.
• Communication: Support documentation for regulatory purposes and co-author scientific reports or manuscripts for publication.

Qualifications - (Education Certification Degree Skills Knowledge etc.)

Education

• MSc or PhD in Biostatistics Statistics or a related quantitative field.

Experience:

• 3-5 years (MSc) or 0-3 years (PhD) of relevant experience or equivalent postdoctoral experience.
• Proficiency in R or SAS is required.
• Direct experience with CDISC implementation (SDTM/ADaM) for regulatory submissions.
• Proven ability to translate complex statistical findings for non-technical stakeholders and collaborators is preferred.
• Proven track record of contributing to grant applications (e.g. ICHR NIH NSF) or high-impact peer-reviewed publications is preferred.
• Proven track record of supporting regulatory submissions and clinical trials Is strongly preferred.

Personal Competencies

• Collaborative and enthusiastic team player with excellent interpersonal and communication skills.
• Proactive self-motivated and solution oriented with strong attention to detail and commitment to accuracy.
• Dependable resourceful and committed to delivering high-quality service.

Working Conditions:

• Required travel between Edmonton API sites.
• This position requires you to be on site.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered ensuring that you and your dependents receive the necessary healthcare support.

Payment in Lieu of Pension: API provides an additional 15% of your annual base salary as an alternative to traditional pension benefits.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days this is subject to job function company needs and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a pre-employment screening which includes background reference checks educational credential verification and criminal reference checks.

This position will remain open until filled.

Required Experience:

IC