Key Responsibilities
Leadership & Project Oversight
- 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.
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).
- Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives.
Data Management & Systems Collaboration
- 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.
Statistical Programming & Analysis
- 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.
Reporting & Scientific Communication
- 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.
Regulatory Compliance & Quality Assurance
- 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.
Collaboration & Stakeholder Engagement
- 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.
Specialized & Strategic Contributions
- 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.
Qualifications
Required
- 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
Preferred
- 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
Posting deadline: This posting will remain open until filled. For best consideration, please apply by July 1, 2026.
Note: Viable applicants will be required to pass a background and education verification check.
