Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Syneos Health, Inc.; The Municipal District of Carlow; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr-Principal Biostatistician for their Medical Affairs team focused on Europe and LATAM. This role involves providing comprehensive statistical support throughout project lifecycles, preparing analysis plans, coordinating with teams, and ensuring high-quality outputs. The ideal candidate will have extensive experience in biostatistics, particularly in diabetes and cardiovascular studies, and be fluent in English. Join us to make a significant impact in clinical development, where your contributions will help improve patients' lives globally.

Benefits

Career development opportunities

Supportive management

Total rewards program

Qualifications

• 5+ years of experience in biostatistics or related field.
• Experience in diabetes and cardiovascular studies preferred.
• Fluent in English, with strong communication skills.

Responsibilities

• Provide statistical support across all assigned tasks during the project lifecycle.
• Prepare Statistical Analysis Plans (SAPs) and documentation.
• Coordinate tasks among biostatistics and programming teams.

Skills

Knowledge of statistical methods for clinical trials

Familiarity with SAS

Understanding of external databases

Project management skills

Ability to work under pressure

Education

Master's in Biostatistics or related field

Tools

SAS

Statistical Analysis Software

Job description

Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Updated: December 4, 2025
Location: Dublin, CW, Ireland
Job ID:25103998-OTHLOC-3582-2DR

Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us 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 the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• This position is open to Europe and LATAM Only - Please submit CVs in English.
• Need to work on 2 projects in diabetes and Cardiovascular.
• Need to know methods for external control arm analyses and time to event analysis.
• Plus, familiarity with the use and biases of external databases is a plus.
• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming 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.
• Creates and 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 all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non‑voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• 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 the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much‑needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health ® (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.