Biostatistician designing real - world evidence studies from EMR and claims data for Syneos Health. Applying causal inference, trial emulation, and statistical programming across healthcare projects.
About the role
- Senior Clinical Scientist leading infectious-disease and HIV clinical trial science at ICON, a global healthcare intelligence and clinical research organisation. Driving protocols, medical monitoring, data review, and regulatory deliverables.
Responsibilities
- Lead or support clinical studies depending on size and complexity
- Ensure clinical/scientific execution of protocols when serving as study lead
- Act as clinical point of contact for scientific issues for internal and external stakeholders
- Lead trial design and endpoint development with Clinical Development
- Lead Medical Monitoring activities, including Medical Monitoring Plan development and SAE report review
- Set up and support SAC, DMC, and adjudication committees
- Collaborate on protocols, amendments, governance reviews, and study-specific documents
- Author protocol clarification letters and review/update informed consent
- Provide scientific input for data management and monitor clinically relevant data issues
- Monitor central laboratory and external safety data
- Prepare and present protocol information at Investigator Meetings
- Serve as scientific lead on the Clinical Trial Team
- Coordinate randomization, laboratory, biospecimen, and imaging specifications
- Participate in database lock activities and collaboratively plan CSRs and CTDs/WMAs
- Support publications and presentations
- Review protocol deviation classifications and prepare deviation lists for CSRs
- Collaborate on trial results communications for investigators
- Provide scientific assessments for operational reviews
- Support study management and medical writing activities to achieve team deliverables
- Mentor other Clinical Scientists as needed
Requirements
- BS/BA in Life Sciences with 7+ yrs clinical research experience
- MS/PhD in Life Sciences with 5+ years clinical research experience
- If no degree in Life Sciences, significant experience in clinical development (>11 years)
- Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required
- Medical monitoring experience required
- Infectious Disease experience required
- HIV experience highly preferred
- Excellent Excel and PP skills required
- Excellent written and oral communication skills
- Ability to travel up to 15% (might include international travel)
- Legally authorized to work in Canada or the US
- Must not require, now or in the future, sponsorship for employment visa status
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
- Reasonable accommodations during the recruitment process
Job title
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