Lead Biostatistician - Clinical Safety

Join our innovative team as a Lead Biostatistician specializing in Clinical Safety, where your expertise in advanced statistical methodologies will drive the success of Phase 1 studies and safety analyses for Phase 2/3 trials, particularly in the area of rare disease programs. In this role, you will also act 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 essential safety analyses for Phase 2/3 clinical trials.

Act as an unblinded DMC statistician, ensuring compliance with sponsor and regulatory standards across multiple studies.

Engage in study design dialogues, contributing to protocol development, dose-escalation strategies, and sample size justification.

Review case report forms (CRFs), data review guidelines, and related documentation to maintain statistical integrity and emphasize safety considerations.

Develop and evaluate Statistical Analysis Plans (SAPs), including specifications for analysis datasets and TLG (tables, listings, graphics) shells.

Perform or supervise safety-focused statistical analyses, interpret results, and effectively convey findings to study teams for Phase 2/3 studies.

Contribute to clinical study reports (CSRs), including detailed integrated safety summaries for regulatory submissions.

Lead statistical activities at the study level as necessary, representing the statistics function on cross-functional teams.

Clearly explain statistical methodologies, underlying assumptions, and the implications of decisions to non-statistical stakeholders.

Work collaboratively in a team-focused environment, demonstrating accountability, flexibility, and a commitment to meeting timelines amidst shifting priorities.

Ensure rapid turnaround times for early-phase studies.

Qualifications & Experience

Required / Preferred:

Master's degree in Statistics, Biostatistics, or a related field; PhD preferred.

5+ years of relevant experience in clinical trials within the pharmaceutical or biotechnology sectors; CRO experience is 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, with R programming experience being a plus.

Solid understanding of ICH guidelines and regulatory expectations.

Strong 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 translate complex statistical concepts into easily understandable terms.

Ability to collaborate effectively, 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.