Remote Lead Biostatistician – Early-Phase Trials

Syneos Health, Inc.; Denmark; Remote; DKK 673,000 - 972,000; Full time

Job summary

Syneos Health is seeking a Principal Statistician in a fully home-based role across Europe. You will lead biostatistics activities across early-phase clinical programs, mentor staff, and drive SAP development and regulatory submissions while coordinating with sponsors and cross-functional teams.

The ideal candidate holds a graduate degree in biostatistics or related field, with extensive trial experience and strong proficiency in R, SAS, and regulatory expectations.

Qualifications

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials and ability to lead multiple projects.
• Program/project level leadership and contributions to clinical development strategy
• Proficiency in R programming.
• Ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

Responsibilities

• Serves as a statistical department resource, mentors biostatisticians and develops training plans for Biostatistics associates.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs) and mock-up displays for tables, listings, and figures; collaborates with sponsor when required.
• May be Lead Biostatistician for protocol statistics and input to the clinical study report.
• Reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS/R annotated CRFs, database design, and other study documentation to meet protocol criteria.
• Implements company objectives and creates solutions to address business challenges.
• As biostatistics representative on project teams, interfaces with other departmental project team representatives.
• Preparing for internal meetings, contributing ideas, and respecting opinions of others.
• Conducts verification and quality control of project deliverables to ensure alignment with SAP.
• May lead complex projects and attend regulatory meetings to support results.
• Manages scheduling across multiple projects and communicates timelines to management.
• Monitors progress and identifies out-of-scope tasks for escalation.
• Provides statistical programming support as needed.
• May participate in DSMB/DMC activities as needed.
• Follows SOPs and regulatory guidelines (ICH) related to statistics.
• Maintains well-organized project documentation and inspection readiness.
• Willing to assist with projects to meet business needs.
• Prepares for internal meetings and contributes ideas.
• Supports business development through proposals and sponsor meetings.
• Performs other duties as assigned.
• Minimal travel may be required.

Skills

R programming

English communication

Education

Graduate degree in biostatistics or related discipline

Job description

Syneos Health is seeking a Principal Statistician in a fully home-based role across Europe. You will lead biostatistics activities across early-phase clinical programs, mentor staff, and drive SAP development and regulatory submissions while coordinating with sponsors and cross-functional teams.

The ideal candidate holds a graduate degree in biostatistics or related field, with extensive trial experience and strong proficiency in R, SAS, and regulatory expectations.