Principal Biostatistician FSP, Clinical Safety (DMC/Unblinded)
- 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.
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