Principal Biostatistician – FTE or Contract

eClinical Solutions

Principal Biostatistician advising life sciences organizations using clinical trial statistics and SAS. Developing analysis plans, datasets, reporting outputs, and regulatory analyses.

Posted 8/18/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesLead💰 $175,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical consulting for clinical trials, including the development and validation of statistical analysis plans, randomization schedules, and compliance with regulatory guidelines. Proficient in SAS programming for clinical trial reporting and data analysis, with strong leadership and communication skills to mentor teams and interact with clinical stakeholders.

Highest-signal resume keywords

SAS ProgrammingStatistical Analysis PlansClinical Study DesignICH, GCP, and 21 CFR Part 11 GuidelinesStatistical Consulting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisData Quality ControlRandomization SchedulesADaM Model DevelopmentSDTM Data StructuresStatistical ReportingInterim AnalysesBlinded Data ReviewsSample Size DeterminationStatistical Programming

Soft Skills

Communication SkillsMultitaskingPrioritizationPlanningOrganization

Tools & Technologies

SASIVRS SpecificationsCoding DictionariesCDISC Data Models

Certifications & Qualifications

SAS CertificationMaster in Statistics or Biostatistics

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryClinical TrialsFDA RequirementsEMEA Requirements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide statistical consulting for clinical trial activities and fulfill study statistician responsibilities
Mentor and perform quality control of statistical programmers’ outputs and define analysis data specifications
Interact with clients and clinical teams, including programmers, clinical data managers, and clinical protocol managers
Develop, review, and finalize statistical analysis plans
Validate programming deliverables and resolve statistical reporting and analysis issues
Develop randomization schedules, specifications, and usage guidelines
Contribute to study-specific data quality control plans and data analysis/reporting
Develop, validate, and finalize tables and table shells for clinical study reports and study deliverables
Ensure clinical team comments on statistical reports are appropriately addressed
Analyze data and support trial progression decisions, including blinded data reviews and interim analyses
Collaborate on regulatory reviews, representations, exploratory, ad-hoc, and post-hoc analyses
Develop SAS programs for analysis datasets and clinical trial reporting, including tables, listings, graphs, queries, and patient profile reports
Ensure compliance with company and industry quality standards, guidelines, and procedures
Perform other duties as assigned

Requirements

What you’ll need

Master in Statistics or biostatistics preferred
SAS® certification preferred
10+ years in the pharmaceutical/biotechnology industry or equivalent statistical consulting and SAS programming role preferred
Strong experience with clinical study design, analysis, and sample size determination
Experience developing randomization schedules, IVRS specifications, and usage guidelines
Excellent knowledge of English and clear, concise, accurate written and verbal communication
Ability to multitask with strong prioritization, planning, and organization skills
Ability and experience delegating tasks and leading projects
Experience working on multiple clinical protocols simultaneously
Ability to balance conflicting priorities
Strong knowledge of ICH, GCP, and 21 CFR Part 11 guidelines, including FDA and EMEA requirements
Experience developing statistical analysis reports and conducting statistical analyses for blinded data reviews and interim analyses
Knowledge of coding dictionaries including WHO, COSTART, ICD-9, and MedDRA
Knowledge of CDISC data models including SDTM and ADaM
Ability to develop ADaM models for clinical trial analysis and reporting
Thorough understanding of SDTM data structures

Benefits

Comp & perks

Remote work
Work-life balance
Inclusive culture
Professional development and career growth opportunities
Equal opportunity employment
Diversity-focused workplace