Principal Biostatistician (LP Oncology - US Remote)

Syneos Health; Morrisville (NC); Remote; USD 95,000 - 176,000; Full time

Job summary

Syneos Health is seeking a Principal Biostatistician to lead biostatistical activities for clinical trials in a remote role available to all US states. The successful candidate will mentor junior biostatisticians, manage project timelines, and ensure the quality and compliance of biostatistical processes. A graduate degree in biostatistics and extensive clinical trial experience are essential for this role, which also offers a competitive salary and comprehensive benefits including health, 401k, and flexible PTO.

Benefits

Health benefits

401k

Stock purchase plan

Bonuses

Flexible PTO

Qualifications

• Extensive experience in clinical trials.
• Leading multiple projects successfully.
• Proficiency in statistical analysis and regulatory submissions.

Responsibilities

• Lead and oversee biostatistics activities across projects.
• Prepare and review statistical analysis plans and related documentation.
• Ensure high-quality outputs and timely completion of tasks.

Skills

Statistical programming

Communication

Regulatory knowledge

Education

Graduate degree in biostatistics or related field

Job description

Join to apply for the Principal Biostatistician (LP Oncology - US Remote) role at Syneos Health.

This position is responsible for leading projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Provides external statistical consultancy for sponsor companies, and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.

Job Responsibilities

• Serve as a statistical department resource, mentor biostatisticians, and oversee training plans or materials.
• Direct activities of biostatistics personnel, ensure timely and high-quality work, and review project outputs.
• Support all statistical tasks during the project lifecycle, from protocol to CSR.
• Prepare or oversee Statistical Analysis Plans (SAPs) and collaborate with sponsors as needed.
• Lead statistical aspects of protocols, generate randomization schedules, and contribute to study reports.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review study documentation to ensure data quality and protocol adherence.
• Implement company objectives, propose solutions to operational challenges, and interface with project teams.
• Participate in verification, quality control, and regulatory interactions.
• Manage project timelines, set goals, and communicate progress.
• Provide statistical programming support and participate in DSMB/DMC activities if applicable.
• Maintain organized documentation and support business development activities.
• Perform other duties as assigned, with minimal travel expected.

Qualifications

• Graduate degree in biostatistics or related field.
• Extensive experience in clinical trials, leading multiple projects.
• Proficiency in programming and knowledge of statistical design, analysis, and regulatory guidelines.
• Experience with regulatory submissions preferred.
• Excellent communication skills in English.

Additional Details

• Remote role open to all US states, no sponsorship required.
• Salary range: $95,000 - $175,700.
• Benefits include health, 401k, stock purchase plan, bonuses, and flexible PTO.

Learn more about us at http://www.syneoshealth.com.