Sr Biostatistician (NA and EMEA Only - Ad-Hoc) Funchal

Sr Biostatistician (NA and EMEA Only - Ad-Hoc)
Madeira
Funchal, Madeira, Portugal

Sr Biostatistician (NA and EMEA Only - Ad-Hoc)

Updated: March 7, 2025

Location: Portugal-Europe - PRT-Home-Based

Job ID:25002186

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

Job responsibilities

This is the position that has a lot of programming. Many ad hoc analyses are initiated by stakeholders and the statistician will explore the data programmatically (SAS and/or R).

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.

• Prepares Statistical Analysis Plans (SAPs), including development of
- presented
- up displays for tables, listings, and figures. Collaborate with the sponsor, if required.

• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.

• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality 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 and all data is captured as required to support a high quality database and the planned analysis.

• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.

• Implements company objectives, and create alternative solutions to address business and operational challenges.

• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.

• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.

• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.

• Provides statistical programming support as needed.

• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent
- voting biostatistician.

• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.

• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e. g. ICH).

• Maintains well organized, complete, and
-
- date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.

• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.

• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

• Coaches and mentors other Biostatistics staff.

• Performs other
- related duties as assigned.

• Minimal travel may be required.

Qualifications

What we’re looking for

• Graduate degree in biostatistics or related discipline.

• Moderate experience in clinical trials or an equivalent combination of education and experience.

• Proficiency in programming.

• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.

• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.

• Excellent written and verbal communication skills.

• Ability to read, write, speak, and understand English.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.