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
- Biostatistician II leading statistical analyses and clinical-trial documentation for Altasciences’ drug-development programs. Using SAS to support sponsors, regulatory submissions, and preclinical projects.
Responsibilities
- Follow department and company standard operating procedures, forms, templates and policies.
- Act as Lead Biostatistician for simple to complex studies and serve as the central point of contact for assigned Biostatistics, internal project and client teams.
- Provide input for Biostatistics project timelines.
- Review study protocols.
- Generate randomization schedules using SAS or randomization-specific software.
- Develop and quality-control statistical analyses, including safety, pharmacokinetic and pharmacodynamic endpoints.
- Develop or assist with Statistical Analysis Plans and table, figure and listing shells.
- Develop summary-statistics tables and graphics for clinical trials.
- Assist with responses to regulatory-agency deficiency letters.
- Use SAS to create and validate inferential statistical programs and results.
- Perform QC reviews of analyses and documents prepared by team members.
- Oversee preclinical projects and direct assigned Biostatisticians with the line manager.
- Coordinate with internal teams to deliver high-quality documents on schedule.
- Represent Biostatistics in client and inter-departmental meetings.
- Conduct work in compliance with SOPs, GCP and regulatory guidelines.
- Maintain awareness of client and internal team expectations and applicable TPD, FDA, EMA, ICH and GCP guidance.
- Participate in or lead quality-improvement initiatives.
- Maintain and participate in department objectives.
- Perform other duties as assigned.
Requirements
- Bachelor's Degree or higher in Statistics or related field required.
- Minimum of 2 Years of related experience preferred.
- SAS, MS Word, Excel, Outlook, MS Teams, and Power Point.
- Ability to read and interpret technical documents and industry specific manuals.
- Ability to write advanced reports and correspondence.
- Ability to speak effectively before groups of customers or employees of the organization.
- Bilingual proficiency in French may be required, depending on location.
- Excellent verbal and written communication skills.
- Professional attitude and strong interpersonal skills.
- Ability to work well with a multi-disciplinary team of professionals.
- Client-focused approach to work.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize workload.
- Superior attention to detail.
- Understanding of clinical research project life cycle and applicable regulatory guidelines.
- Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to information technology (IT) systems as needed.
- Moderate SAS programming proficiency.
- Fluency in English is an essential requirement.
Benefits
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Review
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