Senior Biostatistician, Real-World Data & Submissions

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

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