Senior Biostatistician (Clinical Trial Experience Required)

This is a senior-level biostatistics opportunity supporting clinical research programs from study design through reporting and submission activities. You will serve as a lead statistical partner across internal teams, clients, and clinical project stakeholders. The role combines hands-on statistical programming with study planning, analysis, documentation, and quality oversight.

Responsibilities

• Serve as the lead Biostatistician for assigned clinical studies and act as the primary statistical contact for internal and external project teams.
• Manage statistical activities against project timelines, proactively communicating schedule changes, risks, and scope adjustments to project and Biostatistics leadership.
• Review case report forms, completion instructions, database designs, and data-edit requirements to support accurate and analysis-ready clinical data.
• Develop or review Interim Analysis Plans, Statistical Analysis Plans, statistical methods, and analysis specifications in alignment with study protocols.
• Develop or review CDISC-compliant SDTM and ADaM dataset specifications, mock tables, listings, figures, and associated programming requirements.
• Independently perform statistical analyses by programming derived datasets and TLFs, while validating statistical programs and reviewing the work of other team members.
• Contribute to clinical study reports, statistical reports, publications, and other documentation by developing or reviewing statistical methods and results sections.
• Support clinical study design, including endpoint selection, power and sample size calculations, randomization and blinding procedures, and statistical methodology within study protocols.
• Develop or review randomization plans, randomization programs, and randomization lists as required.
• Ensure statistical activities comply with applicable SOPs, project conventions, Good Clinical Practice, and ICH guidelines.
• Maintain complete and accurate records of statistical work and ensure required documentation is filed appropriately within electronic trial master files.
• Support business development activities by developing study bids, scope changes, and materials for capabilities presentations.
• Contribute to departmental SOPs, work instructions, training initiatives, and team meetings while mentoring and supporting junior Biostatisticians.

Requirements

• Master’s degree in Biostatistics, Statistics, or a closely related quantitative discipline.
• At least 4 years of relevant biostatistics experience within a pharmaceutical, CRO, clinical research, or comparable statistical environment.
• Demonstrated clinical trial experience with the ability to independently lead or oversee statistical activities across the study lifecycle.
• Hands-on experience with CDISC standards, including SDTM and ADaM dataset mapping and related analysis specifications.
• Experience developing or reviewing Statistical Analysis Plans, Interim Analysis Plans, TLF specifications, statistical reports, and clinical study documentation.
• Strong knowledge of clinical study design, endpoint development, power analysis, sample size estimation, randomization, and statistical methodology.
• Experience with statistical programming, derived datasets, TLF development, program validation, and peer review.
• Familiarity with GCP and ICH guidelines and the quality standards required for regulated clinical research.
• BLA/NDA submission experience is preferred, including exposure to regulatory meeting preparation, attendance, and follow-up communications.
• Experience providing statistical consulting or guidance to internal and external clients is a strong advantage.
• Therapeutic experience in transplantation, autoimmune diseases, kidney or liver disease, oncology, or rare diseases is preferred.
• Strong project management, communication, documentation, and stakeholder collaboration skills.
• Ability to mentor junior team members, contribute to departmental initiatives, and manage multiple priorities while maintaining high-quality deliverables.

Benefits

• Fully remote work arrangement within the United States.
• Full-time position with opportunities to contribute to impactful clinical research programs.
• Structured mentoring and leadership development programs to support career progression.
• Ongoing professional education, training, and tuition reimbursement opportunities.
• Comprehensive health and wellness benefits.
• Generous vacation and paid time-off programs.
• Paid parental leave and family-friendly benefits.
• Work-life balance supported through flexible work arrangements.
• Opportunities to work on therapies addressing serious and chronic medical conditions and contribute to meaningful advancements in healthcare.
• Collaborative, international working environment with exposure to clinical research professionals across multiple regions.
• Opportunities for professional growth within a global clinical research and consulting environment.