Responsibilities:

• Compile, write, edit, and coordinate medical writing deliverables
• Complete a variety of documents, including clinical study protocols and protocol amendments, clinical study reports, patient narratives, and investigator brochures
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, company and/or client-approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and lead document reviews
• Review statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency
• Interact and build good working relationships with clients, department head, and peers as necessary
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to resolve document issues, escalating as appropriate
• Continue professional development to grow awareness of industry standards and best practices
• Be aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership
• Complete required administrative tasks within the specified timeframes
• Perform other work-related duties as assigned
• Minimal travel may be required (less than 25%).

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Job Data by YubHub.

Responsibilities:

• Contribute to the design of RWE studies, including protocol development, ability to lead statistical analysis plans (SAPs), and other key study documents with minimal/modest supervision
• Apply comprehensive knowledge of real-world data sources to inform study design, feasibility assessments, and methodological decisions
• Perform advanced statistical analyses using SAS, R, Python, SQL, and/or other appropriate tools
• Develop operational definitions, code lists, and analytical specifications aligned with study objectives and industry standards
• Prepare high-quality tables, figures, and listings (TFLs) and contribute to study reports, manuscripts, and client deliverables
• Provide client-facing support, including presenting planning and project updates, explaining methodologies, addressing technical questions, and contributing to strategic discussions

Requirements:

• Master's degree or higher in Biostatistics, Statistics, Epidemiology, Public Health, Health Economics, Bioinformatics, Computer Science, or a related quantitative discipline
• 5 years (minimum of 3 years) of project-based experience conducting RWE research using secondary healthcare data sources
• 5 years (minimum of 2 years in a consulting setting) of hands-on statistical programming experience (e.g., SAS, R, Python, SQL) in a research or consulting setting
• Strong understanding of RWE methodologies, observational study designs, bias and confounding control methods, and data governance considerations
• Excellent written and verbal communication skills in English, with client-facing experience and preparing deliver-ready results and presenting to stakeholders

Job Data by YubHub.