Jobs at Syneos Health

The Principal Biostatistician leads biomarker analysis for clinical studies, develops evaluation plans, conducts data analyses, mentors staff, and ensures accurate statistical deliverables while collaborating across teams.

Support country-level clinical trial start-up activities including preparing and submitting EC/RA documents, tracking submission timelines and milestones, ensuring TMF document submission, monitoring basic financials, assisting with site selection, and supporting contract and budget negotiations under supervision.

Support sponsor-dedicated clinical studies across Canada by preparing Health Canada and REB/IRB submissions, maintaining regulatory files and CTSI documentation, tracking milestones, processing invoices, supporting start-up/closeout, and managing 15+ concurrent protocols while ensuring compliance and inspection readiness.

Manage site oversight, clinical and central monitoring, and site closeout to ensure patient safety, protocol/GCP/regulatory compliance and data integrity. Identify and mitigate trial risks, coordinate cross-functional teams, maintain study tools and systems, oversee CRAs/monitors, provide training, report status to sponsors, and support inspection readiness.

Oversee clinical trial operations focusing on patient safety, data integrity, and compliance while leading site management and team collaboration.

The role involves programming and data review for real-world data analysis, supporting epidemiologists, and managing complex data sets using statistical programming languages and tools.

Lead and deliver operational and financial management of complex global clinical projects from proposal through closeout. Serve as primary client liaison, manage cross-functional teams, ensure GCP and regulatory compliance, maintain project tracking and inspection readiness, oversee budgets and deliverables, mentor/line-manage junior PMs, support business development, and implement risk mitigation and resource strategies. Travel ~25%.

The Clinical Trial Manager II oversees clinical trials, ensuring compliance with regulations, managing site interactions, and coordinating teams to meet project milestones.

Design and analyze real-world evidence studies using EMR and claims data. Develop SAPs/protocols, apply causal inference and trial-emulation methods, construct external control arms, perform sample size and power calculations, write cohort definitions in SQL, and translate results for HEOR, regulatory, and clinical stakeholders.

Senior data analyst/programmer using SAS or R to analyze commercial claims and EHR real-world data. Create longitudinal cohorts, derive baseline/outcome variables, assess data quality, apply epidemiologic study designs and statistical methods (regression, survival), review protocols/SAPs, and program TFLs. Familiarity with OMOP CDM and OHDSI tools is a plus; prior pharmaceutical experience preferred.

Lead statistical programmer developing SAS code and ADaM-specified datasets, tables, listings, and graphs for clinical trials. Ensures quality, validation, documentation, inspection readiness, mentors programmers, manages timelines, participates in sponsor meetings, and follows regulatory and SOP requirements.

Lead accounting functions including SR&ED claims, income/indirect/transaction tax audits, SOX controls, month/quarter/year-end close, GL reconciliations, tax filings (GST/QST), Oracle Fusion ledger support, and audit/statutory deliverables while collaborating with international teams.

Perform site qualification, initiation, monitoring (on-site or remote) and close-out to ensure ICH-GCP/GPP and protocol compliance. Verify informed consent, source documents, CRF data, IP handling, ISF/TMF reconciliation, and query resolution. Document activities, support recruitment/retention, prepare for audits, train/mentor junior CRAs, and manage site communications and timelines. May support Real-World Late Phase tasks including chart abstraction and country-level regulatory coordination.

Lead RWD analysis strategy and execution: develop technical specifications and statistical programs, perform complex observational analyses (propensity scoring, ML), validate cohorts/variables, ensure QC, collaborate cross-functionally, and communicate results to non-technical stakeholders.

Conduct site qualification, initiation, monitoring, management, and close-out visits to ensure protocol, regulatory and ICH/GCP compliance. Review source documents and CRFs, manage queries, investigational product handling, ISF/TMF reconciliation, documentation, and support audit readiness. Act as liaison with sites and sponsors, support recruitment/retention, and may train junior staff. Heavy travel (up to 75%).

The Director of Epidemiology Pipeline collaborates on virology clinical trials, providing scientific expertise, leading project proposals, and overseeing study management and regulatory compliance.

Design and deliver rater training, perform eligibility reviews, analyze endpoint and clinical data, advise on protocol and endpoint strategy, and collaborate cross-functionally to identify risks and protect study integrity for global clinical trials.