Senior Biostatistician

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

📋 Description

• Act as the primary biostatistician on clinical study teams, responsible for statistical deliverables, quality assurance, and adherence to timelines.

• Mentor and provide guidance to statisticians and statistical programmers.

• Update leadership on project progress, potential risks, and resource requirements.

• Ensure project execution aligns with departmental and organizational objectives.

• Direct the statistical design of clinical studies, including the development of protocols and statistical methodologies.

• Conduct and evaluate sample size and power calculations.

• Create, review, and finalize statistical analysis plans (SAPs).

• Suggest innovative statistical methods, endpoints, and reporting strategies that align with study goals.

• Offer statistical input for electronic data capture (EDC) design.

• Collaborate with data management to establish edit checks and guarantee high-quality data collection.

• Ensure study data is adequate for interim and final analyses as well as regulatory compliance.

• Develop, validate, or supervise statistical programming using SAS and other tools (e.g., R, Python).

• Verify outputs for precision, quality, and compliance with established standards.

• Lead the creation and review of interim analyses, final study reports, and regulatory submissions.

• Convey complex statistical concepts and findings to non-statistical stakeholders and senior management.

• Ensure adherence to GCP, FDA, ICH, and other relevant regulatory standards.

⛳️ Requirements

• PhD or Master’s degree in Biostatistics, Statistics, or a related field, with a minimum of 5 years of experience in clinical trial data analysis.

• Proven programming expertise in SAS (version 9.0 or higher).

• Experience in supporting Phase I–III clinical trials.

• Strong understanding of ICH guidelines and regulatory requirements; familiarity with FDA submission processes.

• Knowledge of CDISC standards (e.g., SDTM, ADaM) for regulatory submissions.

• Demonstrated leadership experience in project management and mentoring team members.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

• Exceptional analytical, organizational, and problem-solving abilities with a keen attention to detail.

• Excellent communication and interpersonal skills, capable of articulating complex statistical concepts clearly.

• Ability to handle multiple trials and priorities simultaneously with minimal impact on productivity.

🏝️ Benefits

• Comprehensive benefits package (including medical, dental, vision, life, STD, LTD, etc.).

• 401(k) matching plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately).

• 11 paid holidays.

• 15 - 25 vacation days depending on years of service.

• Paid sick time (2.67 hours accrued bi-weekly, up to a maximum of 80 hours).

• Monthly fun events (such as team-building activities, games, charitable events, potlucks, and picnics).

• Flexible and remote work schedules.