Principal DMC Biostatistician

Cytel; Toronto; On-site; CAD 100,000 - 140,000; Full time

Job summary

A clinical research organization in Toronto is seeking a Principal Biostatistician to lead teams in creating unblinded statistical reports for data monitoring committees. Candidates should have a Master's or PhD in Biostatistics or related field, with significant industry experience and prior DMC exposure. Strong organizational skills and expertise in statistical methodologies are essential for this role.

Qualifications

• 6+ years of industry experience with a PhD or 8+ years with a Master’s degree.
• Prior unblinded DMC experience required.
• Working knowledge of medical/scientific terminology.

Responsibilities

• Leads teams in creating unblinded reports for DMCs.
• Implements a variety of statistical methodologies.
• Presents statistical reports to DMCs and clients.
• Provides guidance for statistical analyses and reports.
• Ensures data blinding and security compliance.
• Serves as primary contact for DMCs.
• Hosts DMC meetings and presents reports.
• Leads project team meetings regularly.
• Facilitates internal and external presentations.
• Coordinates with non-DMC Cytel functional groups.

Skills

Expert level knowledge of statistical concepts

Strong organizational skills

Excellent verbal communication

Excellent written communication

Ability to multi-task

Education

Master’s degree or PhD in Biostatistics, Statistics, or related field

Job description

The Principal Biostatistician leads teams of biostatisticians and statistical programmers in creating unblinded reports of confidential, ongoing clinical trial data for DMCs. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.

Responsibilities

• Implements a wide variety of statistical methodologies

• Presents statistical reports to DMCs and clients.

• Provides guidance and oversight of biostatistics and programming teams in production of statistical analyses and reports, including interim analyses and adaptations, for DMCs.

• Ensures blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related SOPs and regulatory requirements.

• Serves as primary contact for DMCs.

• Hosts DMC meetings and presents unblinded reports to the DMC in closed meeting sessions.

• Leads and facilitates project team meetings on a regular basis.

• Develops and facilitates internal and external presentations, as appropriate.

• Interact and coordinate with non-DMC Cytel functional groups.

Qualifications

• Master’s degree or PhD in Biostatistics, Statistics, or related field.

• With PhD, a minimum of 6 years of industry experience, with MS a minimum of 8 years of industry experience.

• Expert level knowledge of statistical concepts with working knowledge of medical/scientific terminology

• Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.

• Prior unblinded DMC experience required.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.