Principal Biostatistician (FTE or Contract)

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

About the role

The Principal Biostatistician will work closely with clients and provide high-level consulting services for statistical analysis, reporting, and statistical programming activities. Responsibilities may include development of the statistics section of protocols, statistical analysis plans, randomization schedules, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis reports. Principal Biostatisticians will also work on statistical programming for development of analysis datasets and clinical tables, listings, and graphs specific to trial reporting requirements. They will ensure all client work meets or exceeds expectations.

Responsibilities

• Provide consulting on statistics activities related to clinical trials
• Fulfill the responsibilities of study statistician as required
• Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications
• Validate the statistical models used for programming, if required
• Act as study statistician, interacting with clients and clinical teams including programmers, clinical data managers, clinical protocol managers, and other relevant personnel
• Ensure programmers receive correct specifications and data at the appropriate time
• Develop, review, and finalize the statistical analysis plan
• Validate programming deliverables and collaborate with team members to resolve issues related to statistical reporting and analysis
• Develop randomization schedules, specifications, and guidelines
• Provide input in finalizing study-specific data quality control plans and ensure appropriate data analysis and reporting
• Develop, validate, and finalize study-specific lists of tables and table shells for clinical study reports
• Address all comments from the clinical team regarding statistical reports for study-specific deliverables
• Analyze data and contribute to trial progression decisions by providing input during trial-specific deliverables, including blinded data reviews and interim analyses
• Collaborate with team members for regulatory reviews, representations, and supporting data analyses, including study or compound-level exploratory analyses, ad-hoc analyses, and post-hoc analyses
• Develop SAS programs to generate analysis datasets and trial-specific reporting, including tables, listings, graphs, queries, and patient profile reports
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures
• Perform other duties as assigned

Requirements

• Master’s degree in Statistics or Biostatistics preferred
• SAS® certification is preferred
• 10+ years in the Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role
• Strong experience with clinical study design development, analysis, and sample size determination
• Experience with development of randomization schedules, including IVRS specifications and guidelines
• Excellent knowledge of English with clear, concise, and accurate written and verbal communication skills
• Detail-oriented with strong multitasking, prioritization, planning, and organizational skills
• Ability to delegate tasks, lead projects, and work on multiple clinical protocols simultaneously
• Strong knowledge of ICH guidelines, GCP, and 21 CFR Part 11 from regulatory agencies including FDA and EMEA
• Experience in developing statistical analysis reports and conducting statistical analyses for trial-level deliverables, including blinded data reviews and interim analyses
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
• Knowledge of CDISC® related data models such as SDTM and ADAM; ability to develop ADAM models for analysis and reporting of clinical trials
• Thorough understanding of SDTM data structures

AI Use Statement

Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.

Benefits

eClinical Solutions is a winner of the 2025 Top Workplaces USA Award for Remote Work and has received numerous Top Workplaces Culture Excellence Awards celebrating exceptional company vision, values, and work-life balance.

eClinical Solutions is a people-first organization with an inclusive culture that values diversity, individual experiences, and continuous learning and improvement.

Pay

US Pay Range: $175,000 - $215,000 USD