POSITION:

Biostatistician

LOCATION:

Scarborough, Ontario

REPORTING TO:

Associate Director, PK & Stats

POSITION DESCRIPTION:

1. Provide statistical expertise for study design of Clinical Study Protocols for pharma clients.
2. Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol
3. Write/contribute to data analysis plans (DAP) ensuring that they meet the objectives defined in the protocol and appropriate regulatory requirements
4. Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses of clinical study data for regulatory submission, conference presentation, and manuscript submission.
5. Contribute to relevant statistical sections of the Clinical Study Reports.
6. Review Clinical Study Protocols and Clinical Study Reports.
7. Serve as the key expert contact for statistical issues for the division, for clients and regulatory authorities.
8. Provide advice and guidance to the data management and statistical programming team.
9. Communicate in timely manner with department regarding analysis progress, to ensure successful attainment and completion of project timelines.
10. Keep informed of statistical components of regulatory requirements and implement appropriate changes to statistical analysis.
11. Write, review and/or revise departmental SOPs as necessary.
12. All other duties as assigned that are deemed appropriate for this position

QUALIFICATIONS & EXPERIENCE:

• Bachelor’s degree in Statistics (with advanced statistics courses) with 3+ years of experience, or Master’s degree in Statistics with 0-1 years of experience
• Proficiency in SAS programming and technical knowledge
• Familiarity and/or working knowledge of current FDA/TPD table format and statistical analysis practice
• Experience with CFR 21.11 requirements (electronic submission)
• Working knowledge of GCP (Good Clinical Practices)
• Strong analytical and problem solving skills
• Ability to work both independently and as part of a team
• Excellent verbal and written communication skills
• Superior organizational skills, efficient and able to multi-task and prioritize effectively

jobs@biovail.com