Job Description
📍 Europe Remote
(Eligible locations: UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Netherlands, Belgium)
Type: Full Time
Syneos Health® is seeking a highly experienced Principal Biostatistician with solid HEOR and/or HTA experience to support global medical affairs and clinical research programs.
Key Responsibilities:
- Â Lead and mentor biostatistics team members; develop and deliver training.
-  Oversee statistical activities across project lifecycles — protocol to CSR.
- Â Prepare and review Statistical Analysis Plans (SAPs) and mock-ups for TLFs.
- Â Serve as Lead Biostatistician on assigned projects, ensuring quality and timelines.
- Â Review CRFs, database designs, and documentation for accuracy and compliance.
- Â Support regulatory submission activities and attend agency meetings when required.
- Â Participate in DSMB/DMC activities (may serve as independent or voting statistician).
- Â Support business development through proposals, budgets, and sponsor meetings.
- Â Ensure inspection-ready documentation and adherence to ICH-GCP, SOPs, and WI.
Qualifications:
- Â Graduate degree in Biostatistics or related field.
- Â Extensive clinical research experience with proven leadership.
- Â Mandatory: Previous experience in HEOR and/or HTA.
- Â Proficiency in statistical programming.
- Â Experience managing multiple studies across all statistical tasks.
- Â Strong communication, organizational, and problem-solving skills.
- Â Experience with regulatory submissions (preferred).
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