Sr​/Pr Biostatistician - Immunology & Inflammation

Overview

Updated:
October 21, 2025

Location:

DEU-Remote
Job :

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.

• 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…