Sr/Pr Biostatistician (Europe and Canada - Oncology)

Syneos Health; Deutschland; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical solutions company is seeking a Sr/Pr Biostatistician to support Oncology Clinical Trials. The role involves statistical programming, preparing analysis plans, and collaborating with teams. A graduate degree in biostatistics and proficiency in SAS and R are required. Excellent communication skills and experience in clinical trials are essential.

Qualifikationen

• Moderate experience in clinical trials or equivalent education/experience.
• Ability to communicate statistical concepts effectively.
• Experience supporting clinical trials from protocol to CSR.

Aufgaben

• Perform statistical programming using SAS or R.
• Support Oncology Clinical Trials from end to end.
• Prepare Statistical Analysis Plans (SAPs) and develop mock-ups.

Kenntnisse

Statistical programming

Proficiency in SAS

Proficiency in R

Communication skills

Understanding of statistical design

Ausbildung

Graduate degree in biostatistics or a related discipline

Tools

SAS

R

Jobbeschreibung

Overview

Sr/Pr Biostatistician (Europe and Canada - Oncology)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical insights into outcomes to address modern market realities. Our clinical development model centers on the customer and the patient, with a focus on simplifying and streamlining work. Depending on arrangements, you may work in a Functional Service Provider partnership or a Full-Service environment, collaborating with teams to accelerate delivery of therapies.

We are a global company with 29,000 employees in 110 countries, where work matters and diverse perspectives help us succeed.

Job Responsibilities

• Must live in Canada, Europe, or LATAM to be considered for this role.
• Perform statistical programming using SAS or R.
• Support Oncology Clinical Trials from end to end, across all assigned statistical tasks from protocol through CSR.
• Prepare Statistical Analysis Plans (SAPs) and develop well-presented mock-ups for tables, listings, and figures; collaborate with the sponsor if required.
• Possibly contribute to the statistical aspects of protocols, randomization schedules, publications, and input to the clinical study report.
• Coordinate activities of biostatistics and statistical programming personnel; provide independent review of work produced by others.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS-annotated CRFs, database design, and study documentation to ensure protocol criteria are met and data support planned analyses.
• Conduct verification and quality control of deliverables; ensure alignment with SAP and specifications; propose solutions to operational challenges.
• Serve as biostatistics representative on project teams; prepare for internal meetings and collaborate respectfully with team members.
• Manage scheduling and timelines across multiple projects; communicate progress and any difficulties to biostatistics management.
• Monitor study milestones and ensure deliverables meet timelines; identify out-of-scope tasks and escalate when needed.
• Provide statistical programming support as needed.
• May participate in Data Safety Monitoring Board / Data Monitoring Committee activities as needed.
• May lead projects involving integrated analyses and respond to regulatory inquiries to support statistical analysis results.
• Follow applicable SOPs, work instructions, and regulatory guidelines (e.g., ICH).
• Maintain organized, up-to-date project documentation and verification/quality control materials; ensure inspection readiness.
• Collaborate with others and assist with projects and initiatives to meet business needs.
• Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
• Coach and mentor other Biostatistics staff.
• May perform other duties as assigned; minimal travel may be required.

Qualifications

• Graduate degree in biostatistics or a related discipline.
• Moderate experience in clinical trials or an equivalent combination of education and experience.
• Proficiency in programming (SAS and/or R).
• Ability to apply knowledge of statistical design, analysis, regulatory guidelines, and programming techniques used in clinical research; ability to communicate statistical concepts effectively.
• Experience across all statistical tasks required to support clinical trials from protocol to CSR.
• Excellent written and verbal communication skills; English proficiency.

About Syneos Health

No matter your role, you’ll be encouraged to take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The company may assign additional tasks as needed. Equal opportunity employer statements and compliance information are provided as part of our standard requirements.