Senior Clinical, Trial Biostatistician

Saratoga Ascend

. Support clinical studies as a senior clinical/trial biostatistician .

Posted 11/5/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study design, statistical analysis plans, and regulatory submissions, with a strong foundation in biostatistics and experience in NIH- or FDA-regulated trials. Proficient in collaborating within multidisciplinary teams and adhering to Good Clinical Practice standards.

Highest-signal resume keywords

Ph.D. In BiostatisticsClinical Study DesignStatistical Analysis PlansSAS ProficiencyGood Clinical Practice Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsPower And Sample Size CalculationsInterim And Final AnalysesTables Listings And Figures ProductionRandomization SchemesClinical Trials SupportPreclinical Studies SupportProtocols And Manuscripts ContributionStatistical Software ProficiencyClinical Research Experience

Soft Skills

CollaborationCommunicationTeamworkProblem-SolvingInterpersonal Skills

Tools & Technologies

SASRStatistical Software

Certifications & Qualifications

Current Human Subjects Protections TrainingGCP Training (CITI or Equivalent)

Industry Keywords

NIH-Regulated TrialsFDA-Regulated TrialsGood Clinical Practice (ICH E6)21 CFR Parts 11, 50, 54, 56, 312 And 81245 CFR Part 46HIPAA

About the role

Key responsibilities & impact

Support clinical studies as a senior clinical/trial biostatistician
Design clinical studies, including small-population and early-phase studies
Develop statistical analysis plans and randomization schemes
Perform power and sample size calculations
Conduct interim and final analyses
Produce tables, listings and figures for DSMB reviews and regulatory submissions
Support preclinical studies
Contribute to protocols, reports and manuscripts
Support NIH- or FDA-regulated clinical research programs
Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team

Requirements

What you’ll need

Ph.D. in biostatistics, statistics or a related quantitative field preferred
Master's degree with substantial equivalent experience acceptable
Minimum of 8 years of experience as a biostatistician on clinical studies (Ph.D.) or 10 years (master's), including NIH- or FDA-regulated trials
Clinical study design, including small-population and early-phase designs
Development of statistical analysis plans and randomization schemes
Power and sample size calculations
Interim and final analyses, and production of tables, listings and figures for DSMB reviews and regulatory submissions
Proficiency in SAS, R or equivalent statistical software
Experience supporting preclinical studies and contributing to protocols, reports and manuscripts
Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
Current human subjects protections and GCP training (e.g., CITI or equivalent)
Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials

Benefits

Comp & perks

Competitive rate
Benefit options
Equal opportunity employment