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Principal Biostatistician
1 month ago
Join to apply for the Principal Biostatistician (Medical Affairs Required) role at Syneos Health
4 days ago Be among the first 25 applicants
- Must be located in UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Netherlands, Argentina, Mexico, Brazil, or Colombia to be considered for this role.
- Must not require Visa Sponsorship to be considered
Please submit all CVs in English. Must be located in the specified countries. Must not require Visa Sponsorship.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model centers on the customer and the patient, aiming to simplify and streamline our work to make Syneos Health both easier to work with and for.
Whether in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.
Discover why our 29,000 employees across 110 countries already know:
Why Syneos Health- We are passionate about developing our people through career development, supportive management, training, peer recognition, and rewards.
- We foster a Total Self culture where you can be authentic. We are dedicated to caring for our people.
- We value diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging.
- Support all statistical tasks during the project lifecycle, from protocol to CSR.
- Prepare Statistical Analysis Plans (SAPs), develop mock-up displays, and collaborate with sponsors as needed.
- Handle statistical aspects of protocols, randomization, publications, and contribute to clinical study reports.
- Coordinate activities of biostatistics and programming personnel, review work for quality and timeliness.
- Create or review programming specifications for analysis datasets, tables, listings, and figures.
- Review study documentation to ensure data quality and analysis readiness.
- Conduct quality control of deliverables, ensuring compliance with SAP and specifications.
- Implement company objectives and develop solutions for operational challenges.
- Serve as biostatistics representative on project teams, prepare for meetings, contribute ideas, and respect others' opinions.
- Manage scheduling, prioritize tasks, and communicate proactively about timeline issues.
- Monitor progress against milestones and escalate issues as needed.
- Provide statistical programming support as required.
- Participate in Data Safety Monitoring Board activities, including charter development and serving as an independent biostatistician.
- Lead analyses, attend regulatory meetings, and respond to inquiries supporting clinical trial results.
- Follow SOPs, WIs, and regulatory guidelines (e.g., ICH).
- Maintain organized documentation and verification/quality control records for inspection readiness.
- Collaborate with others and assist with projects and initiatives.
- Support business development through proposals, budgets, and meetings.
- Mentor other biostatistics staff.
- Perform other duties as assigned. Minimal travel may be required.
- Graduate degree in biostatistics or related field.
- Moderate experience in clinical trials or equivalent education/experience.
- Proficiency in programming.
- Knowledge of statistical design, analysis, regulatory guidelines, and communication of statistical concepts.
- Experience supporting all statistical tasks during a project lifecycle.
- Excellent written and verbal communication skills.
- Fluent in English (reading, writing, speaking).
Over the past 5 years, we've worked with 94% of FDA-approved drugs, 95% of EMA products, and over 200 studies across numerous sites and patients. Join us in a dynamic, innovative environment where initiative and challenging the status quo are valued.
Additional InformationTasks and responsibilities are not exhaustive. The company may assign other duties at its discretion. Equivalent experience, skills, and education will be considered. This description does not create a contract. We comply with all applicable legislation and are committed to an inclusive, accessible workplace.
Seniority level- Mid-Senior level
- Full-time
- Research, Analyst, and Information Technology
- Biotechnology Research, Pharmaceutical Manufacturing, Research Services
