Biostatistician CONSULTANT

About the role

Estimated commitment averages 2–3 hours per week, with increased support required during key study milestones.

Responsibilities

• Provide statistical input for clinical study design and protocol development.
• Develop endpoint selection and sample size justification strategies.
• Design randomization strategies and conduct PK/PD and exposure–response analyses.
• Author and review Statistical Analysis Plans (SAPs).
• Review, interpret, and validate Tables, Listings, and Figures (TLFs).
• Support preparation and review of Clinical Study Reports (CSRs) and regulatory submission documents.
• Perform ad hoc analyses including efficacy and safety analyses, subgroup analyses, PK/PD modeling support, exposure–response assessments, data trending, and exploratory analyses.

Essential Skills

• Expertise in biostatistics.
• Experience in clinical trial biostatistics.
• Proficiency in SAP authoring and statistical analysis planning.
• Ability to review and interpret TLFs.
• CSR and regulatory submission support experience.
• PK/PD and exposure–response analysis expertise.

Additional Skills & Qualifications

• Ability to communicate statistical findings to both technical and non-technical stakeholders.
• Collaborative skills to work with Clinical Development, Clinical Pharmacology, Data Management, Programming, and Regulatory teams.

Work Environment

This is a 100% remote position.

Pay

The pay range for this position is $90.00 – $100.00 per hour. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental, and vision coverage.
• Critical illness, accident, and hospital indemnity insurance.
• 401(k) retirement plan with pre-tax and Roth post-tax contribution options.
• Voluntary life and AD&D insurance for the employee and dependents.
• Short- and long-term disability coverage.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Paid time off, vacation, and sick leave.