Descripción de la oferta
Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA)
Updated: TodayLocation: Madrid, SpainJob ID:25109875-OTHLOC-3529-2DMAD-2DR
Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA)
As a biostatistician with Syneos Health, you will provide support across all assigned statistical tasks throughout the lifecycle of clinical projects. Your responsibilities include developing and reviewing Statistical Analysis Plans (SAPs), coordinating activities of the biostatistics and statistical programming team, creating programming specifications, and ensuring compliance with SOPs and regulatory guidelines. You may also provide statistical programming support, participate in data safety monitoring and regulatory meetings, and mentor junior staff.
Supports scientific design of the clinical studies and prepares Statistical Analysis Plans (SAPs) including mock-up displays for tables, listings, and figures.
Coordinates activities of other biostatistics and statistical programming personnel to ensure timely, high-quality output and provides independent review of project work.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
Conducts verification and quality control of project deliverables, ensuring outputs align with SAP and specifications.
Serves as biostatistics representative on project teams and interfaces with other departmental representatives.
Manages scheduling and time constraints across multiple projects, sets priorities, adapts to timeline changes, and communicates challenges to biostatistics management.
Monitors progress on study activities against milestones and ensures deliverables are met, escalating out-of-scope tasks to management.
Provides statistical programming support as required.
Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, as needed.
Leads integrated analyses, attends regulatory agency meetings, and responds to questions regarding statistical analysis results on behalf of the sponsor.
Follows applicable SOPs, WI, and regulatory guidelines such as ICH.
Maintains comprehensive, up-to-date project documentation and verification/quality control records, ensuring inspection readiness.
Displays teamwork, assists with projects, and supports business development activities such as proposals, budgets, and sponsor bid defense meetings.
Coaches and mentors other biostatistics staff.
Performs additional related duties as assigned.
Travel may be required minimally.
Summary
PhD/MS in statistics or a related discipline with at least 3 years of pharmaceutical experience. Strong knowledge of advanced statistical concepts and methods. Proficiency in SAS or R, and experience with meta-analyses and late-phase clinical trials is highly preferred.
Equal Opportunity Employer
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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