Sr/Pr Biostatistician - Immunology & Inflammation at Syneos Health

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Overview

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient, enabling agile collaboration across Functional Service Provider and Full-Service environments.

Responsibilities

• Study lead for 1-2 protocols (late phase, phase 2-3); for phase 3, may support another main statistic
• Support activities including IRT, eCRF, DMC setup, SRMP, SAP, tables/listings/figures (tfls, STS)
• Review specifications and perform statistical surveillance (STS); participate in 2-3 STS meetings during study life
• Handle intercurrent events; apply SAS or R for analyses; may partially program efficacy
• Provide support across all assigned statistical tasks from protocol through CSR
• Prepare SAPs with well-presented mock-up displays; collaborate with sponsor as required
• Possibly responsible for statistical aspects of protocol, randomization schedule, publications, and input to the CSR
• Coordinate activities of biostatistics and statistical programming staff to ensure timely, high-quality work; provide independent review of peers
• Create or review programming specs for analysis datasets, tables, listings, and figures
• Review SAS-annotated CRFs, database design, and study documentation to meet protocol criteria and ensure high-quality data capture
• Conduct verification and QC of deliverables; ensure outputs align with SAP and specifications
• Implement company objectives and propose alternative solutions for business and operational challenges
• Act as biostatistics representative on project teams; prepare for internal meetings and work collaboratively
• Manage scheduling and time constraints across multiple projects; communicate challenges to biostatistics management
• Monitor progress against milestones and adjust timelines as needed; escalate out-of-scope tasks
• Provide statistical programming support as needed
• May participate in Data Safety Monitoring Board or Data Monitoring Committee activities
• May lead projects involving integrated analyses; attend regulatory agency meetings or respond to questions to support statistical analysis results
• Follow SOPs, WIs, and regulatory guidelines (e.g., ICH); maintain organized project documentation and verification/quality control documents
• Demonstrate willingness to collaborate; support business development activities (proposals, budgets, sponsor bid defense meetings)
• Coach and mentor other Biostatistics staff; perform other duties as assigned; minimal travel may be required

Required Qualifications

• Strong background in biostatistics within immunology & inflammation contexts
• Experience with SAS or R; ability to develop SAPs and support CSR preparation
• Ability to coordinate cross-functional teams and manage multiple projects
• Experience with study design, SDS, SDS management, and data quality assurance

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. Get involved in a culture that values collaboration and impact. Learn more at Syneos Health.

Additional information: Tasks, duties, and responsibilities are not exhaustive. The Company may assign other tasks. Equal opportunity employer information and compliance statements are provided as required.