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.

Key Responsibilities

You will contribute by:

• 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.

Qualifications & Experience

Required / Preferred:

• 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.