Senior Principal Biostatistician - Clinical Safety

Join our dynamic team as a Senior Principal Biostatistician, where you will utilize your expertise in advanced statistical methodologies to spearhead Phase 1 studies and perform safety analyses for Phase 2/3 trials, with a keen focus on rare disease programs. This role also encompasses serving as an unblinded statistician for Data Monitoring Committees (DMC) across various studies. Key Responsibilities Provide statistical leadership and support for early-phase studies, while conducting vital safety analyses for Phase 2/3 clinical trials. Serve as an unblinded DMC statistician, ensuring adherence to sponsor and regulatory standards across multiple studies. Engage in study design discussions, contributing to protocol development, dose-escalation strategies, and sample size justification. Review case report forms (CRFs), data review guidelines, and related documentation to ensure both statistical integrity and safety considerations are met. Develop and assess Statistical Analysis Plans (SAPs), including specifications for analysis datasets and TLG (tables, listings, graphics) shells. Execute or oversee safety-focused statistical analyses, interpret results, and effectively communicate findings to study teams for Phase 2/3 studies. Contribute to clinical study reports (CSRs), including comprehensive integrated safety summaries for regulatory submissions. Lead statistical activities at the study level as necessary, representing the statistics function within cross-functional teams. Clearly articulate statistical methodologies, underlying assumptions, and the implications of decisions to non-statistical stakeholders. Collaborate effectively in a team-oriented environment, demonstrating accountability, flexibility, and commitment to meeting timelines amidst changing priorities. Demonstrate quick turnaround times for early-phase studies. Qualifications & Experience Required / Preferred: Master's degree in Statistics, Biostatistics, or a related field; PhD strongly preferred. 5+ years of relevant experience in clinical trials within the pharmaceutical or biotechnology sectors; CRO experience highly desired. Proven expertise in: Leading early-phase clinical trials Conducting safety analyses for Phase 2/3 clinical trials Performing sample size calculations and developing protocol concepts Creating SAPs and preparing clinical study reports Knowledge of regulatory submissions (preferred) Extensive experience serving as an unblinded DMC statistician. Strong command of advanced statistical methods and their practical applications. Proficiency in SAS programming, particularly for quality control of critical outputs, safety and efficacy tables, and collaboration with statistical programmers; R programming experience is a plus. Solid understanding of ICH guidelines and regulatory expectations. Robust knowledge of CDISC standards (SDTM/ADaM) relevant to regulatory submissions. Hands-on experience with ADaM dataset specification development and quality control. Experience working in cross-functional, matrixed teams, effectively representing the statistics function. Exceptional written and verbal communication skills, with the ability to convey complex statistical concepts in understandable terms. Ability to work collaboratively, meet aggressive timelines, and adapt to evolving priorities. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Created: 2026-03-11