Role Overview
In this role, you will be responsible for the statistical integrity, protocol design, sample size estimation, and SAS/R programming across global Phase I-IV clinical trials. You will interface with clinical study teams, medical monitors, and regulatory authorities to ensure all data standardizations adhere strictly to CDISC SDTM and ADaM models.
Key Challenges & Impact
Core Challenge Solved
Achieving Pinnacle 21 validation compliance with zero data discrepancies across complex, multi-cohort adaptive trial datasets.
Your statistical modeling and rigorous CDISC standardization enable Pharmaleaf's sponsor partners to present rock-solid evidence packages to global regulatory agencies during approval reviews.
Key Responsibilities
- Develop comprehensive Statistical Analysis Plans (SAP) and mock Tables, Figures, and Listings (TFLs).
- Perform sample size calculations, randomization schedules, and interim analysis statistical modeling.
- Lead CDISC SDTM and ADaM dataset architecture, spec authoring, and Pinnacle 21 compliance validation.
- Write, validate, and execute complex SAS and R statistical macros for efficacy and safety evaluations.
- Provide statistical input into clinical study protocols, investigator brochures, and Clinical Study Reports (CSRs).
- Support FDA, EMA, and PMDA regulatory responses, briefing documents, and advisory committee presentations.
Qualifications & Requirements
- Master's or PhD in Biostatistics, Statistics, Applied Mathematics, or related quantitative field.
- 3+ years of biostatistical experience in clinical trial design and analysis within a CRO or pharma environment.
- Expert proficiency in SAS (STAT, GRAPH, MACRO) and R programming.
- In-depth knowledge of CDISC SDTM, ADaM, and Define.xml submission standards.
- Familiarity with regulatory statistical guidance (ICH E9, E9(R1) Addendum on Estimands and Sensitivity Analysis).