Principal Statistical Analyst

Redbock - an NES Fircroft company

San Francisco (CA)

On-site

USD 150,000 - 210,000

Full time

5 hours ago
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Job summary

Redbock - an NES Fircroft company is seeking a Principal Statistical Analyst to lead statistical programming for clinical trial data, ensuring data integrity and regulatory-ready outputs. You will develop SAS programs, validate analysis datasets, and support multiple studies across development stages.

The role requires 14+ years of experience, CDISC expertise, and strong collaboration with cross-functional teams to deliver high-quality analysis, tables, figures, and submissions.

Qualifications

  • Bachelor's or master's in Statistics, Mathematics, Biostatistics, CS, Life Sciences or related field.
  • 14+ years of statistical programming experience in pharma/biotech/CRO/clinical research.
  • Extensive hands-on SAS experience for analysis and reporting.
  • Strong knowledge of CDISC standards (SDTM/ADaM).
  • Experience supporting regulatory submissions and study reporting.
  • Excellent written and verbal communication; ability to manage multiple priorities.

Responsibilities

  • Develop/validate SAS programs to generate analysis datasets, TLFs, and other deliverables.
  • Create and maintain analysis dataset specifications and supporting docs.
  • Ensure timely, accurate delivery of programming outputs across studies.
  • Follow established programming standards, processes, and best practices.
  • Perform quality control reviews of outputs and documentation for regulatory submissions.
  • Support development of CDISC-compliant deliverables and analyses.
  • Contribute to clinical study reporting, regulatory submissions, publications, and other deliverables.
  • Produce and validate ad hoc analyses and data reviews for stakeholders.
  • Review SAPs, programming specs, study reports, and related documents for accuracy.
  • Collaborate with statisticians, data management, and clinical teams to support study objectives.

Skills

SAS programming
Statistical analysis
Cross-functional collaboration
Communication skills
Regulatory submissions

Education

Bachelor's or Master's in Statistics/Biostatistics/Math/CS/Life Sciences

Tools

SAS

Job description

We are seeking an experienced Principal Statistical Analyst to support the analysis, validation, and reporting of clinical trial data in a dynamic and collaborative research environment. This individual will play a key role in delivering high-quality programming outputs, ensuring data integrity, and supporting regulatory and clinical development activities across multiple studies.

Key Responsibilities
  • Develop and/or independently validate SAS programs used to generate analysis datasets, tables, listings, figures (TLFs), and other clinical trial deliverables.
  • Create and maintain analysis dataset specifications and supporting documentation.
  • Ensure timely, accurate, and high-quality delivery of programming outputs across assigned studies and projects.
  • Follow established programming standards, processes, and best practices.
  • Perform quality control reviews of clinical data outputs and related documentation to support internal decision-making and external regulatory submissions.
  • Support the development of CDISC-compliant deliverables, including SDTM and ADaM datasets, associated documentation, and analysis outputs.
  • Contribute to clinical study reporting, regulatory submissions, publications, and other research-related deliverables.
  • Produce and validate ad hoc analyses, data reviews, and presentation materials for cross-functional stakeholders.
  • Review Statistical Analysis Plans (SAPs), programming specifications, study reports, presentations, and related documents to ensure accuracy and consistency.
  • Collaborate closely with statisticians, data management, clinical teams, and other functional groups to support study objectives.
Qualifications
  • Bachelor's or Master's degree in Statistics, Mathematics, Biostatistics, Computer Science, Life Sciences, or a related field.
  • 14+ years of statistical programming experience within the pharmaceutical, biotechnology, CRO, or clinical research industry.
  • Extensive hands‑on experience using SAS for clinical trial data analysis and reporting.
  • Strong knowledge of CDISC standards, including SDTM and ADaM.
  • Experience supporting regulatory submissions and clinical study reporting activities.
  • Excellent written and verbal communication skills.
  • Proven ability to manage multiple priorities, work independently, and thrive in a cross‑functional team environment.
  • Industry experience supporting clinical development programs is required.
Preferred Qualifications
  • Experience supporting oncology clinical trials.
  • Strong attention to detail with a commitment to data quality and regulatory compliance.
  • Demonstrated ability to learn quickly and adapt to changing priorities.
  • Collaborative mindset with a track record of working effectively across teams.
  • Interest in leveraging innovative tools, technologies, and processes to improve efficiency and quality.

This is an excellent opportunity for a senior‑level programming professional who enjoys working in a fast‑paced clinical development environment and contributing to the successful delivery of high‑impact research programs.

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