Senior Biostatistician (Clinical Trial Experience Required)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Biostatistician (Clinical Trial Experience Required) based in United States.

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.
You will contribute to SAPs, IAPs, CDISC-compliant datasets, TLFs, randomization, and clinical study reports.
The position also offers opportunities to mentor junior statisticians and contribute to departmental standards and processes.
You will work within a GCP/ICH environment where statistical rigor, regulatory compliance, and high-quality delivery are essential.
This role is well suited to an experienced biostatistician who enjoys clinical trial work, client collaboration, and end-to-end study ownership.

Accountabilities

• 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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