Principal Biostatistician (Medical Affairs/HEOR - Europe Only)

Syneos Health group; City of London; Hybrid; GBP 55,000 - 80,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Principal Biostatistician (Medical Affairs/HEOR) to support statistical activities across various programs. The ideal candidate will have extensive clinical trial experience and HEOR knowledge. Responsibilities include mentoring biostatisticians, directing project activities, and preparing analytical plans. This is an opportunity to contribute to impactful projects within a dynamic team in the UK.

Qualifications

• Must have previous experience with HEOR and/or HTA.
• Extensive experience in clinical trials or equivalent combination of education and experience.
• Ability to apply extensive knowledge of statistical design and analysis.

Responsibilities

• Mentors biostatisticians and develops training.
• Directs activities of biostatistics personnel on projects.
• Prepares Statistical Analysis Plans and oversees statistical tasks.

Skills

HEOR experience

Statistical programming

Excellent communication skills

Clinical trial experience

Education

Graduate degree in biostatistics or related discipline

Job description

Principal Biostatistician (Medical Affairs/HEOR - Europe Only)

Syneos Health is seeking a Principal Biostatistician (Medical Affairs/HEOR - Europe Only). This role supports statistical activities across HEOR and medical affairs programs, collaborating with sponsors and cross-functional teams to deliver high-quality statistical analyses and documentation throughout the project lifecycle.

Job Responsibilities

• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions or trains new hires to enhance skills.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians in the department.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.
• May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedules, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met and data is captured as required to support a high-quality database and planned analysis.
• Implements company objectives and creates alternative solutions to address business and operational challenges.
• As biostatistics representative on project teams, interfaces with other departmental project team representatives.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables, ensuring output meets the expected results and aligns with the SAP and specifications.
• May lead complex or multiple projects (e.g., submissions, integrated analyses), and attend regulatory agency meetings or respond to questions as needed to support statistical analyses on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on management priorities, discusses time estimates for completion with biostatistics management, and communicates any difficulties meeting timelines.
• Monitors progress on study activities against milestones and ensures study timelines for project deliverables are met. Identifies out-of-scope tasks and escalates as needed.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
• Maintains well-organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet business needs.
• Supports business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
• Performs other work-related duties as assigned. Minimal travel may be required.

Qualifications

• Must have previous experience with HEOR and/or HTA.
• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
• Proficiency in programming.
• Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

Location

• Open to hiring in the following locations: UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Netherlands, Belgium.

Get to know Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success and translating clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes as equivalent qualifications. This description is not an employment contract. The Company adheres to applicable laws and equal opportunity requirements.