Senior Biostatistician – Real-World Data

princeps technologies; United States; On-site; USD 130,000 - 170,000; Part time

Job summary

princeps technologies is seeking a Senior Biostatistician to lead statistical activities for active regulatory submissions. Focus areas include observational and real-world studies, methodological rigor, and submission readiness.

The role requires strong collaboration with Biometrics, Regulatory Affairs, Medical Writing, and CROs in a fast-paced environment. The ideal candidate has 9+ years in biostatistics, MS/PhD, SAS expertise, and experience supporting NDA/IND/MAA submissions, with a track

Qualifications

• MS or PhD in Statistics, Biostatistics, or related field.
• 9+ years in pharma/biotech.
• Experience in real-world/observational studies.
• Experience supporting NDA/MAA/IND submissions.
• Strong of statistical methodology and study design.
• SAS proficiency required.

Responsibilities

• Provide statistical and methodological expertise across projects.
• Lead statistical deliverables with internal teams, CROs, and partners.
• Validate analyses and deliverables.
• Plan/ad hoc analyses using observational and real-world data.
• Contribute to CSRs and regulatory submissions.
• Support IND, NDA, MAA submissions and regulatory reviews.
• Review third-party analyses and ensure traceability of results.
• Reconstruct workflows into submission-ready ADaM structures.
• Manage multiple projects with timelines and quality.

Skills

SAS

R/Python

CDISC SDTM/ADaM

Regulatory submissions

Study design

Analytical methods

Education

MS/PhD in Statistics/Biostatistics

Tools

Snowflake

CRO oversight tools

Job description

Senior Biostatistician – Real-World Data & Regulatory Submissions

Job Type: [Contract]

Experience: 7+ years

Education: MS or PhD in Statistics, Biostatistics, or a related discipline

About the Role

We are seeking an experienced Senior Biostatistician to serve as a statistical lead supporting an active regulatory submission program for a leading pharmaceutical organization.

The role will focus primarily on observational and real-world studies, with responsibilities spanning statistical review, submission readiness, analysis traceability, reviewer-facing documentation, and cross-functional resolution of statistical and data-related issues.

The ideal candidate will have strong experience with Real-World Data (RWD), rare disease, and regulatory submissions, and be comfortable working in a fast-paced environment with compressed timelines and close collaboration across Biometrics, Regulatory Affairs, Medical Writing, Statistical Programming, CROs, and external partners.

Key Responsibilities

• Provide statistical and methodological expertise across assigned projects.
• Lead and coordinate statistical deliverables with internal teams, CROs, and external partners.
• Validate key statistical analyses and deliverables.
• Plan and conduct ad hoc and exploratory statistical analyses using observational and real-world data.
• Contribute to Clinical Study Reports (CSRs), including statistical methodology and interpretation of results.
• Lead statistical activities supporting IND, NDA, MAA, and other regulatory submissions.
• Respond to statistical questions and comments from the FDA and other regulatory agencies.
• Review and challenge analyses delivered by CROs and external vendors.
• Reconstruct third-party analysis workflows and translate them into submission-ready ADaM structures.
• Ensure end-to-end traceability of statistical results back to datasets and source analyses.
• Identify and resolve statistical and data-related issues in collaboration with cross-functional teams.
• Manage multiple statistical projects and priorities simultaneously while maintaining quality and timelines.

Required Qualifications & Skills

• MS or PhD in Statistics, Biostatistics, or a related quantitative discipline.
• 9+ years of experience in the pharmaceutical or biotechnology industry.
• Demonstrated experience in the analysis and reporting of real-world and observational studies, including retrospective and prospective studies.
• Experience supporting NDA, MAA, IND, or other regulatory submissions.
• Strong knowledge of statistical methodology and study design.
• SAS programming proficiency is required.
• Experience with R, Python, and/or Snowflake is a plus.
• Strong understanding of CDISC standards, including SDTM, ADaM, and eSub requirements.
• Experience overseeing statistical deliverables provided by CROs and external contractors.
• Ability to independently lead statistical activities across multiple projects.
• Strong analytical, problem-solving, and communication skills.
• Ability to work independently, take initiative, and operate effectively under tight timelines.

Preferred Experience

• Experience in rare diseases, immunology, and/or gene therapy.
• Strong background in Real-World Data (RWD) and Real-World Evidence (RWE).
• Experience with regulatory interactions and submission-related statistical activities.
• Experience reviewing, challenging, and validating third-party statistical analyses.
• Experience with analysis traceability and submission-ready data structures.