Senior Biostatistician & Trial Design Lead

Statistics & Data Corporation (SDC); Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive pay

Generous time off

Attainable career advances

Positive work/life balance

401(k) matching (U.S.)

Job summary

Statistics & Data Corporation (SDC) is seeking a Principal Biostatistician to lead biostatistics on clinical studies and mentor junior staff. You will review SAPs, write statistical sections of protocols and reports, and ensure regulatory compliance while guiding timelines and budgets.

You will also support business development through proposals and capability presentations, acting as a domain expert in client meetings and managing study budgets.

Qualifications

• Master’s degree in biostatistics, statistics, or a related field with four years of relevant professional experience
• PhD in biostatistics, statistics, or a related field with three years of relevant experience
• Equivalent combination of experience and education may be considered

Responsibilities

• Act as an internal consultant for biostatistics analysis tools and methods.
• Serve as a subject‑matter expert during client and vendor meetings for biostatistics analysis support.
• Actively support business development in capabilities presentations to prospective and current clients.
• Effectively manage assigned clinical study budgets for biostatistics analysis support.
• Develop, coach, and mentor junior biostatistics department personnel.
• Lead statistician on clinical research projects and assist with SAS programming.
• Provide statistical expertise for study design of clinical trial protocols.
• Write statistical methods sections of study protocols and SAPs as needed.
• Write statistical analysis plans ensuring regulatory requirements and study objectives are followed.
• Review CRFs for protocol and SAP alignment.
• Program summary tables and data listings for trials.
• Perform analyses defined in SAP and post‑hoc analyses.
• Prepare/ review key sections of clinical study reports and regulatory documents.
• Perform statistical QC of outputs.
• Support external clients with statistical questions (FDA, investigators).
• Contribute to SOP development, maintenance, and training.
• Represent biostatistics in regulatory and sponsor meetings.
• Manage biostatistics timelines, budgets, and client expectations.
• Adhere to SDC quality system and data integrity requirements.
• Perform other duties as needed.
• Maintain compliance with regulatory requirements.

Skills

Leadership

Analytical thinking

Independent worker

Project management

Statistical programming

SAS data analysis

Data quality issues

Convey technical concepts

Organization & time management

Regulatory knowledge

Cross-functional collaboration

Quality focus

Education

Master’s degree in biostatistics or related field

PhD in biostatistics or related field

Tools

SAS

Job description

Statistics & Data Corporation (SDC) is seeking a Principal Biostatistician to lead biostatistics on clinical studies and mentor junior staff. You will review SAPs, write statistical sections of protocols and reports, and ensure regulatory compliance while guiding timelines and budgets.

You will also support business development through proposals and capability presentations, acting as a domain expert in client meetings and managing study budgets.