cpc
Senior Biostatistician
Aurora, Colorado, United States · Senior
Sponsorship not specified$15k-$25kDetected 20 days ago
PythonGCPData AnalysisStatisticsComplianceBusiness DevelopmentExcelHRClinical TrialsFDA RegulatorySASResearchExperimental DesignLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingMicrosoft OfficeBiostatistics
About the role
- 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.
Responsibilities
- Serve as the lead biostatistician on clinical study teams, accountable for statistical deliverables, quality, and timelines.
- Study Design & Statistical Strategy
- 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).
- 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).
- Lead preparation and review of interim analyses, final study reports, and regulatory submissions.
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
- Excellent communication and interpersonal skills, with the ability to convey complex statistical concepts clearly
- Required
- Strong analytical, organizational, and problem-solving skills with high attention to detail
- Ability to manage multiple trials and priorities simultaneously with minimal disruption to productivity
- Preferred
Nice to have
- Leadership & Project Oversight
- 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.
- Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives.
- Data Management & Systems Collaboration
- Statistical Programming & Analysis
- Review outputs for accuracy, quality, and compliance with standards.
Compensation
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
Benefits
- CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- 15 - 25 vacation days based on years of service
- Flexible and remote work schedules
Equal opportunity
- An Equal Opportunity Employer
- CPC is dedicated to the principles of equal employment opportunity (EEO).
- equal opportunity and that selection decisions be based on job-related factors.
- Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws.
This listing is sourced directly from cpc's careers page and normalized into a canonical job model.