Principal Biostatistician (Integrated analysis experience required) EU based

Syneos Health, Inc.; Polska; On-site; PLN 394,000 - 656,000; Full time

Job summary

Syneos Health, an EU-based remote role, seeks a Principal Biostatistician with integrated analysis experience to lead projects across multiple studies and act as the primary statistics consultant for sponsors.

You will mentor biostatisticians, supervise deliverables from protocol to CSR, develop SAPs, and contribute to regulatory submissions while upholding rigorous statistical standards and collaboration across teams.

Qualifications

• Graduate degree in biostatistics or related discipline – Master Degree (minimum).
• Integrated analysis experience.
• Strong submission and clinical development expertise.
• Regulatory and cross-functional experience.
• Extensive experience in clinical trials or equivalent combination of education and experience.
• Proficiency in programming.
• Ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

Responsibilities

• Mentor biostatistics staff and train new hires; oversee training materials.
• Direct activities of other biostatistics personnel to ensure timely, high-quality work.
• Provide support across all statistical tasks from protocol to CSR.
• Prepare or oversee SAPs and develop displays for tables, listings, and figures.
• Lead statistical aspects of protocols, randomization, and input to CSR.
• Create or review programming specifications for datasets and figures.
• Review study documentation to ensure data capture meets criteria and supports analysis.
• Ensure quality and inspection readiness; communicate timelines to management.
• Possibly lead complex projects or regulatory submissions and participate in sponsor meetings.

Skills

Integrated analysis

Biostatistics expertise

Regulatory submissions

Clinical development knowledge

Programming

Communication

English proficiency

Education

Master's degree in Biostatistics

Job description

Principal Biostatistician (Integrated analysis experience required) EU based

Updated: September 24, 2026
Location: Remote, MZ, Poland
Job ID:25112456-OTHLOC-3553-2DR

Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:

Why Syneos Health

• 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

JOB SUMMARY

This position is responsible for leading projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Provides external statistical consultancy for sponsor companies, and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.

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 otherwise trains new hires and enhance the skills of existing personnel.
• 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 Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (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.
• 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
• Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
• May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics 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 (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 the needs of the business.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

QUALIFICATION REQUIREMENTS

• Graduate degree in biostatistics or related discipline – Master Degree (minimum)
• Integrated analysis experience – hands-on experience with IASAP and TLF specifications, additional derivations, draft table reviews, and planning/coordinating analyses to support labeling.
• Strong submission and clinical development expertise – deep understanding of clinical development plans and submission strategy, with experience contributing to submission planning and Benefit/Risk analyses.
• Regulatory and cross-functional experience – ability to independently manage regulatory authority requests and effectively partner with clinical teams, including providing ad-hoc analytical support for publications and other clinical needs.
• 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.

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.

Summary

Principal Biostatistician with integrated analysis experience along with lead Study Stat experience

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 improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.