Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Syneos Health, Inc.; São Paulo; Presencial; BRL 160.000 - 200.000; Tempo integral

Resumo da oferta

A biopharmaceutical solutions organization is seeking a Sr-Principal Biostatistician to lead biostatistical initiatives in medical affairs projects focused on diabetes and cardiovascular conditions in LATAM. Responsibilities include developing statistical analysis plans, coordinating staff activities, and ensuring high-quality project delivery. Candidates should have a Master's or PhD in Biostatistics or a related field and proven experience in statistical programming. Strong communication and project management skills are essential.

Qualificações

• Proven experience in biostatistics and statistical programming.
• Ability to work across multiple projects with scheduling constraints.
• Experience with regulatory agency interactions and responses.

Responsabilidades

• Lead biostatistical analysis for projects in diabetes and cardiovascular areas.
• Develop Statistical Analysis Plans and mock-up displays.
• Coordinate biostatistics staff activities for timely delivery.

Conhecimentos

Biostatistical leadership

Statistical programming

Project management

Communication skills

Formação académica

Master's or PhD in Biostatistics or related field

Ferramentas

SAS

Descrição da oferta de emprego

Sr-Principal Biostatistician – Medical Affairs (Europe and LATAM ONLY)

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates innovation in clinical development. This role focuses on biostatistical leadership for medical affairs projects in Europe and Latin America.

Our Clinical Development model places the customer and the patient at the center of everything we do. We work to simplify and streamline our work to make Syneos Health a great place to work.

Job Responsibilities

• Work on two projects in diabetes and cardiovascular therapeutic areas.
• Develop and execute methods for external control arm analyses and time‑to‑event analysis.
• Provide support across the lifecycle of the project, from protocol development to the Clinical Study Report.
• Prepare Statistical Analysis Plans (SAPs) and mock‑up displays for tables, listings, and figures.
• Coordinate activities of biostatistics and statistical programming staff, ensuring timely delivery of high‑quality work.
• Review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS‑annotated CRFs, database designs, and other study documentation to verify protocol criteria.
• Participate in verification and quality control of project deliverables.
• Implement alternative solutions to address business and operational challenges.
• Represent biostatistics on project teams, interfacing with other departmental representatives.
• Manage scheduling and time constraints across multiple projects, communicating proactively with biostatistics management.
• Monitor progress against milestones and identify out‑of‑scope tasks.
• Provide statistical programming support as needed.
• May participate in Data Safety Monitoring Board or Data Monitoring Committee activities.
• May lead integrated analyses, attend regulatory agency meetings, or respond to questions.
• Follow applicable SOPs, WIs, and regulatory guidelines (e.g. ICH).
• Maintain well‑organized and up‑to‑date project documentation and verification/quality control records.
• Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
• Coach and mentor other biostatistics staff.
• Perform other work‑related duties as assigned.
• Travel may be required.

Additional Information

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks or duties with no prior notice. Equivalent experience, skills, and/or education may be considered. The Company complies with relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act, and offers reasonable accommodations as needed.

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