Principal Biostatistician, FSP

Clinical Outcomes Solutions

. Lead one Phase I-IV clinical study across the region .

Posted 10/13/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in biostatistics and clinical trial support, with a strong focus on advanced statistical methodologies, study design, and regulatory submissions. Proficient in R and SAS for statistical analyses and data visualization, with a collaborative approach to cross-functional team leadership.

Highest-signal resume keywords

Biostatistics ExperienceStudy Design ExpertiseAdvanced Statistical MethodsR Programming ProficiencyRegulatory Submission Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsStudy DesignSample Size DeterminationProtocol DevelopmentStatistical Analysis PlansEfficacy AnalysesMixed ModelsLongitudinal AnalysesSimulation MethodologiesExploratory Statistical Analyses

Soft Skills

Excellent Communication SkillsCollaborative MindsetAbility to Manage AmbiguityAdaptability to Changing PrioritiesCommitment to High-Quality Work

Tools & Technologies

RSASCDISC Standards

Industry Keywords

Clinical TrialsPharmaceutical IndustryBiotechnology IndustryICH GuidelinesRegulatory Expectations

About the role

Key responsibilities & impact

Lead one Phase I-IV clinical study across the region
Provide statistical and development support and influence for associated client trials
Provide expertise in processes, clinical development plans, concept sheets, and protocols
Potentially provide oversight of work supported by other vendors
Formulate integrated analytical approaches to mine data sources
Employ statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate processes
Participate in development of study protocols, including study design discussions and sample size calculations
Participate in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout development
Apply advanced statistical methodologies, including mixed models and other complex modeling techniques, to support efficacy and longitudinal analyses
Design and execute simulation studies to evaluate study designs, operating characteristics, and statistical methodologies
Lead and contribute to efficacy analyses and interpretation of primary and secondary endpoints
Review CRFs and data review guidelines; develop Statistical Analysis Plans, including analysis dataset and TLF specifications
Perform statistical analyses and interpret statistical results
Lead study activities when called upon and provide strategic statistical guidance to cross-functional teams
Present statistical methodology, assumptions, and implications of decisions in clear, non-technical language
Collaborate with cross-functional teams and adapt as project priorities evolve

Requirements

What you’ll need

Master's degree in Statistics, Biostatistics, or a related discipline
8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry
3-5 years of Study Lead experience working with cross-functional development teams
Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE)
Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies
Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making
Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling
Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers
Strong knowledge of ICH guidelines and regulatory expectations
Solid understanding and implementation of CDISC standards for regulatory submissions
Experience generating ADaM specifications and performing programmatic review of analysis datasets
Regulatory submission experience (ISS/ISE) strongly desired
Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences
Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines
Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities

Benefits

Comp & perks

Consistent training, development and support
Significant professional growth
Professional development opportunities through staff development