Senior Biostatistician

CPC Clinical Research • Aurora, CO

2d • Hybrid

About The Position

CPC is seeking a Senior Biostatistician to serve as the lead biostatistician on clinical study teams. This role is accountable for statistical deliverables, quality, and timelines, and involves providing mentorship and oversight to statisticians and statistical programmers. The Senior Biostatistician will communicate project progress, risks, and resource needs to leadership, ensuring alignment with departmental and organizational goals. The position also involves leading the statistical design of clinical studies, including protocol development and statistical methodologies, performing sample size and power calculations, and developing statistical analysis plans (SAPs). Collaboration with data management for EDC design and edit checks, as well as ensuring data quality for analyses and regulatory requirements, is crucial. The role requires developing, validating, or overseeing statistical programming using SAS and other tools, and guiding programming specifications and reporting frameworks. Preparation and review of interim analyses, final study reports, and regulatory submissions, along with contributions to scientific communication through manuscripts and presentations, are key responsibilities. Ensuring compliance with GCP, FDA, ICH, and other regulatory standards, maintaining audit-ready documentation, and contributing to SOP development are also essential. The Senior Biostatistician will collaborate with various internal and external stakeholders, including regulatory agencies and data monitoring committees, and support business development initiatives. Specialized contributions include statistical consulting, supporting randomization design, unblinded statistician roles, and integrated summaries of safety and efficacy.

Requirements

• PhD or Master’s degree in Biostatistics, Statistics, or related field with at least 5 years of experience in clinical trial data analysis
• Demonstrated programming proficiency in SAS (version 9.0 or higher)
• Experience supporting Phase I–III clinical trials
• Strong knowledge of ICH guidelines and regulatory requirements; familiarity with FDA submission processes
• Familiarity with CDISC standards (e.g., SDTM, ADaM) for regulatory submissions
• Proven leadership experience managing projects and mentoring team members
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint)
• Experience working on integrated summaries of safety and efficacy (ISS/ISE) or similar large-scale reporting efforts
• Strong analytical, organizational, and problem-solving skills with high attention to detail
• Excellent communication and interpersonal skills, with the ability to convey complex statistical concepts clearly
• Ability to manage multiple trials and priorities simultaneously with minimal disruption to productivity

Nice To Haves

• Experience with FDA/NDA submissions and regulatory interactions
• Experience working in a client-facing or CRO environment
• Therapeutic area expertise
• Proficiency in R, Python, or other advanced analytical tools
• Track record of contributions to publications, abstracts, or conference presentations

Responsibilities

• Serve as the lead biostatistician on clinical study teams, accountable for statistical deliverables, quality, and timelines.
• Provide mentorship and oversight to statisticians and statistical programmers.
• Communicate project progress, risks, and resource needs to leadership.
• Ensure alignment of project execution with departmental and organizational goals.
• Lead the statistical design of clinical studies, including protocol development and statistical methodologies.
• Perform and review sample size and power calculations.
• Develop, review, and finalize statistical analysis plans (SAPs).
• Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives.
• Provide statistical input into electronic data capture (EDC) design.
• Partner with data management to define edit checks and ensure high-quality data collection.
• Ensure study data supports interim and final analyses and regulatory requirements.
• Develop, validate, or oversee statistical programming using SAS and other tools (e.g., R, Python).
• Review outputs for accuracy, quality, and compliance with standards.
• Guide programming specifications, table shells, and reporting frameworks.
• Lead preparation and review of interim analyses, final study reports, and regulatory submissions.
• Contribute to manuscripts, abstracts, integrated summaries, and ad hoc analyses.
• Communicate complex statistical concepts and results to non-statistical stakeholders and senior leadership.
• Ensure compliance with GCP, FDA, ICH, and other applicable regulatory standards.
• Maintain audit-ready documentation and high-quality, submission-ready deliverables.
• Contribute to the development and refinement of statistical SOPs and best practices.
• Collaborate with clinical operations, data management, physicians, and external partners.
• Interface with regulatory agencies, data monitoring committees, and steering committees.
• Build strong client relationships and support business development initiatives.
• Provide statistical consulting across therapeutic and technical domains.
• Support specialized activities such as randomization design, unblinded statistician roles, and integrated summaries of safety and efficacy.
• Represent the organization through publications, conference participation, and professional engagement.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

What This Job Offers

• Job Type: Full-time
• Career Level: Senior