Principal Biostatistician FSP, Late Phase

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Biostatistician FSP, Late Phase based in the United States.

This is an exceptional opportunity for an experienced biostatistics professional to contribute to the development of innovative therapies within a collaborative, sponsor-embedded environment. The role offers significant involvement in late-phase clinical trials, where you will provide statistical leadership across study design, analysis, interpretation, and regulatory submissions. Working alongside multidisciplinary clinical development teams, you will help generate high-quality evidence that supports critical drug development decisions and advances patient care. The position combines scientific rigor, technical expertise, and strategic collaboration in a fast-paced research setting. Ideal candidates will enjoy influencing study outcomes, mentoring colleagues, and working closely with stakeholders across clinical, regulatory, and data management functions. This role provides both professional growth and the opportunity to make a meaningful impact on global healthcare innovation.

• Provide statistical leadership and support for Phase II and Phase III clinical trials, ensuring the application of sound statistical methodologies throughout the study lifecycle.
• Collaborate with cross-functional teams to establish study objectives, timelines, analysis strategies, and data interpretation plans.
• Author and review Statistical Analysis Plans (SAPs), analysis dataset specifications, and tables, listings, and figures (TLF) documentation.
• Perform and oversee efficacy and safety analyses using industry-standard statistical programming tools while ensuring the accuracy and integrity of study outputs.
• Guide and support statistical programmers in the development, validation, and quality review of analysis datasets and reporting deliverables.
• Interpret clinical study results and contribute statistical expertise to study reports, regulatory submissions, and scientific communications.
• Support exploratory analyses and provide statistical consultation to Clinical Development, Clinical Operations, Data Management, and related teams.
• Participate in regulatory submission activities, including INDs, NDAs, integrated summaries, annual reports, and briefing documents.
• Monitor project timelines, deliverables, resource allocation, and vendor activities to ensure successful execution of statistical deliverables.
• Contribute to continuous improvement initiatives and uphold industry standards, regulatory expectations, and best practices in biostatistics.

Requirements

• PhD in Statistics, Biostatistics, or a related quantitative discipline with at least 5 years of relevant industry experience, or a Master’s degree with at least 7 years of industry experience.
• Minimum of 3 years of experience supporting Phase II and/or Phase III clinical trials within the pharmaceutical, biotechnology, or clinical research industry.
• Strong expertise in statistical methodologies applied to clinical research and drug development.
• Proficiency in SAS and/or R for statistical analysis, programming, validation activities, and production of clinical trial deliverables.
• Experience developing and reviewing ADaM datasets, TLFs, and statistical analysis documentation.
• Solid knowledge of CDISC standards, including SDTM, ADaM, and CDASH.
• Understanding of ICH E9, ICH GCP, regulatory requirements, and industry best practices for clinical trial conduct and reporting.
• Experience with multiple imputation methods and advanced statistical techniques used in clinical research.
• Excellent communication, collaboration, and stakeholder management skills with the ability to work independently and proactively.
• Strong analytical thinking, problem-solving capabilities, and attention to detail in a highly regulated environment.
• Preferred experience interacting with health authorities, participating in advisory committee activities, or supporting regulatory meetings.
• Additional experience within renal, nephrology, central nervous system (CNS), or related therapeutic areas is highly desirable.

Benefits

• Competitive annual base salary ranging from $115,900 to $243,900, based on qualifications, experience, location, and other relevant factors.
• Fully remote, home-based work opportunity within the United States.
• Flexible work schedules that support a healthy work-life balance.
• Long-term project stability through dedicated sponsor partnerships and redeployment opportunities.
• Exposure to innovative pharmaceutical and biotechnology development programs.
• Opportunities to contribute directly to regulatory submissions and late-stage clinical development activities.
• Access to technical training, professional development resources, and customized career growth programs.
• Collaborative environment with highly skilled statistical, clinical, and research professionals.
• Engaging and fast-paced work setting focused on advancing new therapies to market.
• Potential eligibility for incentive compensation, bonuses, and comprehensive health and welfare benefits, depending on employment terms.