Principal Biostatistician FSP, Clinical Safety; DMC​/Unblinded

As a Principal Biostatistician, you will leverage advanced statistical methodologies to leading Phase 1 studies as well as conducting safety analyses for Phase 2/3 trials, with a particular focus on rare disease programs. This position will also serve DMC unblinded statisticians across multiple studies.

• Providing statistical leadership and support for early phase studies and as well as conducting safety analyses for Phase 2/3 trials.
• Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
• Participating in study design discussions, including protocol development, dose‑escalation strategies, and sample size justification.
• Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed.
• Developing and reviewing Statistical Analysis Plans (SAPs), including analysis dataset specifications and TLG shells.
• Performing and/or overseeing safety‑focused statistical analyses, interpreting results, and communicating findings to study teams for phase 2/3 studies.
• Preparing and contributing to clinical study reports (CSRs), including integrated safety summaries for regulatory submissions.
• Leading statistical activities at the study level when required and representing the statistics function in cross‑functional teams.
• Clearly explain statistical methodology, assumptions, and implications of decisions to non‑statistical stakeholders.
• Collaborating effectively as a team player, demonstrating accountability, flexibility, and a commitment to meeting timelines in a dynamic environment.
• Quick turnaround time in early phase studies.

• Master’s degree in Statistics, Biostatistics, or a related discipline;
  PhD strongly preferred.
• 5+ years of experience supporting clinical trials within the pharmaceutical or biotechnology industry; CRO experience strongly preferred.
• Demonstrated experience in:
  • Leading early phase clinical trials
  • Conduct safety analyses for phase 2/3 clinical trials
  • Sample size calculations and protocol concept development
  • SAP development and clinical study report preparation
  • Regulatory submissions (preferred)
  • Proven experience serving as an unblinded DMC.
  • Strong knowledge and practical application of advanced statistical methods.
  • Proficient SAS programming skills, particularly for QC of critical outputs, safety/efficacy tables, and collaboration with statistical programmers; R programming experience is a plus.
  • Solid understanding of ICH guidelines and regulatory expectations.
  • Strong working knowledge of CDISC standards (SDTM/ADaM) for regulatory submissions.
  • Hands‑on experience with ADaM dataset specification development and QC.
  • Experience working in cross‑functional, matrixed teams, effectively representing the statistics function.
  • Excellent written and verbal communication skills, with the ability to translate complex statistical concepts into lay terms.
  • Demonstrated ability to work collaboratively, meet aggressive timelines, and remain flexible as priorities evolve.

Cytel Inc. is an Equal Employment / Affineative 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.