Principal Biostatistician/Senior Principal Biostatistician

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

📋 Description

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

• Consults with clients on clinical trial study design and regulatory strategies.

• Develops and reviews statistical methodologies for clinical study protocols.

• Provides and/or verifies calculations for sample sizes.

• Authors statistical analysis plans for complex study designs.

• Evaluates statistical analysis plans created by other biostatisticians.

• Reviews statistical outputs to ensure their accuracy.

• Assesses statistical sections of clinical study reports.

• Generates and/or verifies randomization schedules.

• Delivers statistical analysis and reporting to Data Monitoring Committees (DMCs) in the capacity of the unblinded reporting biostatistician.

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

• Acts as a Subject Matter Expert (SME), developing and reviewing procedural documents, and participating in new initiatives.

• Mentors and trains fellow statisticians.

• Participates in bid defense meetings for complex programs.

• Performs additional duties as assigned.

⛳️ Requirements

• For Senior Principal Biostatistician level: 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 level: 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.

• Comprehensive experience with regulatory submissions.

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

• Advanced understanding of statistical methodologies (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures).

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

• Proficiency in SAS.

🏝️ Benefits

• This position is also eligible for a discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance options.

• Disability benefits.

• Parental leave policies.

• Paid time off for sick leave and vacation.