Sr. Biostatistician consultant

Senior Biostatistician
6+ Month Renewable Contract
Remote (U.S.)
Overview
An innovative clinical-stage biotechnology organization is seeking a Senior Biostatistician to support a growing portfolio of development programs. This consultant will play a key role in the design, analysis, and reporting of clinical studies while partnering closely with cross-functional teams, external vendors, and regulatory stakeholders.
This is a hands-on statistical leadership position responsible for supporting study design, protocol development, statistical analysis planning, data interpretation, and regulatory deliverables across multiple clinical programs.
Key Responsibilities
Provide statistical input for clinical study design, protocol development, sample size calculations, CRFs, and clinical study reports.
Author and review Statistical Analysis Plans (SAPs), including derivation specifications and TFL shells.
Support interpretation and communication of clinical trial results.
Collaborate with data management and other functional groups to ensure data quality and study execution.
Oversee CRO biostatistics and programming vendors, ensuring high-quality deliverables and adherence to timelines.
Contribute to regulatory submissions and agency interactions.
Support statistical analyses for annual safety reports, investigator brochures, and other periodic regulatory deliverables.
Partner with cross-functional teams to drive study objectives and maintain project timelines.
Required Qualifications
PhD in Statistics, Biostatistics, or a related quantitative discipline.
4+ years of biostatistics experience within the pharmaceutical, biotechnology, or life sciences industry.
Strong expertise with Multiple Imputation (MI) methodologies.
Advanced SAS programming knowledge and the ability to review statistical outputs.
Recent experience supporting regulatory submissions and late-stage clinical development programs.
Experience managing external CROs and statistical programming vendors.
Strong understanding of clinical development, statistical methodologies, and global regulatory requirements.
Excellent communication and cross-functional collaboration skills.
Additional Information
Fully remote opportunity.
Candidates located in any U.S. time zone will be considered.
Must be available for regular collaboration with teams operating on Pacific Time.
Initial 6+ month contract with strong potential for extension.
This version removes identifying details such as the company size, location, therapeutic focus, rare disease reference, and pipeline description, making it much more difficult for competitors to determine the client.

Work arrangement
No