Principal Biostatistician/Senior Principal Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Offers statistical leadership and support throughout all stages of clinical development.

• Advises clients on clinical trial study design and regulatory strategies.

• Develops and reviews statistical methodologies for clinical study protocols.

• Calculates and/or verifies sample sizes.

• Writes statistical analysis plans for complex study designs.

• Assesses statistical analysis plans prepared by fellow biostatisticians.

• Evaluates statistical outputs to ensure precision.

• Reviews statistical sections within clinical study reports.

• Creates and/or validates randomization schedules.

• Delivers statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician.

• Collaborates proactively with sponsors, internal study teams, and external vendors.

• Acts as a Subject Matter Expert (SME) and develops/reviews procedural documents while contributing to new initiatives.

• Mentors and trains other statisticians.

• Participates in bid defense meetings for complex programs.

⛳️ Requirements

• For Senior Principal Biostatistician: Master's degree or equivalent in Statistics, Biostatistics, or a related field with 12+ years of experience; or a PhD in Statistics, Biostatistics, or a related field with 9+ years of experience.

• For Principal Biostatistician: Master's degree or equivalent in Statistics, Biostatistics, or a related field with 10+ years of experience; or a PhD in Statistics, Biostatistics, or a related field with 7+ years of experience.

• Extensive experience with regulatory submissions.

• Significant experience advising clients on clinical trial study design and regulatory strategies.

• Exceptional understanding of statistical methodologies (e.g., Bayesian adaptive study design, survival analysis, repeated measures).

• Strong knowledge of industry standards such as ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.

• Proficiency in SAS.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.