Syneos Health, Inc. is hiring: Sr/Pr Biostatistician - Immunology & Inflammation
Syneos Health, Inc., Germany, OH, United States
Overview
Updated: October 21, 2025
Location: DEU-Remote
Job ID: 25102409
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 places the customer and the patient at the center of everything we do, and we continually seek ways to simplify and streamline our work to better serve our customers and patients.
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 dedicated to changing lives.
Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
- We continuously build the company we want to work for and that our customers want to work with. We believe diversity of thoughts, backgrounds, cultures, and perspectives creates a sense of belonging for everyone.
Job Responsibilities
- Study lead 1-2 protocol (late phase, phase 2-3)
- For phase 3, may support another main statistic
- IRT, eCRF, DMC setup
- Study risk management plan (SRMP)
- Prepare SAP, tables, listings, and figures (tfls, STS)
- Review specifications
- STS (statistical surveillance), reviewing blinded data, 2-3 STS meetings during study life
- Recruiting the right patients; assess data quality and statistical assumptions
- Handling intercurrent events; SAS or R; may partially program the efficacy
- Provide 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 schedules, 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 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 all data is captured to support a high-quality database and planned analysis.
Conducts and participates in verification and quality control of project deliverables, ensuring output meets expectations and aligns with SAP and specifications.
Implements company objectives and creates alternative solutions to address business and operational challenges.
Serves as biostatistics representative on project teams, including preparing for internal meetings, contributing ideas, and respecting diverse opinions.
Manages scheduling and time constraints across multiple projects, sets goals based on management priorities, and communicates any difficulties with timelines to biostatistics management.
Monitors progress on study activities against milestones and ensures study timelines for 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 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 to support statistical analysis results of clinical trials on behalf of the sponsor.
Follows applicable SOPs, work instructions, and relevant regulatory guidelines (e.g. ICH). Maintains 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.
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 your role, you’ll take initiative and challenge the status quo in a highly competitive environment. Learn more about Syneos Health.
Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign additional tasks at its discretion. Equivalent experience, skills, and/or education will be considered. This description is intended to comply with applicable laws and regulations, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate to perform the essential functions of the job.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage joining our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart to bring therapies to patients who need them. A career with Syneos Health means your everyday work improves patients’ lives globally.
Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We support a diverse, equitable and inclusive culture.
Phone: 919 876 9300
Fax: 919 876 9360
Toll-Free: 866 462 7373
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodations to complete any part of our application process, please contact us at: Email: jobs@syneoshealth.com