Jobs at Syneos Health

Develops and validates SAS programs to generate tables, listings, figures, and datasets per SAP and specifications; leads and mentors programmers; ensures quality, documentation, inspection readiness, and compliance with SOPs and regulatory guidelines; participates in sponsor meetings and manages multiple project timelines.

Lead statistical programmer using SAS to develop tables, listings, figures, and derived datasets per SAP and specifications. Validate outputs, maintain documentation, ensure regulatory compliance, mentor and direct other programmers, participate in sponsor meetings, manage multiple projects and timelines, and support inspection readiness. Minimal travel possible.

Lead and mentor Clinical Data Associates across data management activities for global clinical trials. Perform EDC build and UAT, data entry/review, discrepancy resolution, QC (including SAS mapping QC), SAE reconciliation, report creation (Discoverer/BOXI/J-Review), liaise with programming/biostatistics/operations, maintain study documentation, and act as backup support for the Project Data Manager as needed.

Provide CMC regulatory support for EU, GCC and AU regions: prepare gap analyses, regulatory submissions (IND, pre-approval, registration, post-approval), manage day-to-day regulatory activities, support agency interactions, prepare estimates and training, participate in audits and SOP maintenance, and provide project oversight.

The Principal Biostatistician in Clinical Pharmacology will lead statistical aspects of clinical studies, contribute to research design, and collaborate with teams to ensure drug development success.

Execute central report review activities to ensure patient safety, protocol/GCP/regulatory compliance, and data integrity. Review site and central monitoring documentation, document revisions and approvals in CTMS, identify and escalate serious issues, record observations and protocol deviations for action, assess report quality and trends, and participate in project meetings and training.

Lead statistical programming for clinical trials using SAS to produce SDTM datasets, tables, listings, and figures. Ensure quality, validation, and regulatory-compliant documentation; mentor and direct other programmers; participate in sponsor meetings and study planning; manage multiple projects and timelines while following SOPs and ICH guidelines.

Develop and validate SAS programs to produce SDTM, ADaM, and TLF outputs per SAP/specs; ensure QC, documentation, and inspection readiness. Lead and mentor programmers, participate in sponsor meetings, provide CDISC/DEFINE.XML guidance, support ISS/ISE and safety/efficacy analyses, and contribute to SOPs and tooling. Minimal travel.

The Project Specialist at Syneos Health will collaborate on biopharmaceutical projects, support customer success, and contribute to clinical development initiatives within a diverse team.

Provide regulatory expertise to support drug development and commercialization, advise on regulatory strategy and compliance, collaborate with clients and cross-functional teams to shape solutions across clinical programs.

The Safety & PV Specialist I is responsible for data entry and tracking of safety reports, maintaining compliance with SOPs, and conducting literature reviews related to safety in clinical trials.

The Sr. Statistical Programmer develops programming code using SAS to generate statistical outputs, ensures quality standards, manages multiple projects, and leads programming teams. Responsibilities include documentation, communication with teams, and mentoring programming personnel while participating in sponsor meetings.