Study Lead Statistician - Product Facing

Target PR Range: 95-105/hr
*Based on experience

Study Lead Statistician (SLS) – Role Overview

The Study Lead Statistician (SLS) for product-facing work leads statistical activities for clinical studies. This role collaborates closely with cross-functional teams to ensure studies are well-designed, statistically sound, compliant with regulatory standards, and aligned with internal practices. The SLS ensures operational and statistical integrity throughout the study lifecycle and supports product-level activities such as regulatory submissions and publications.

The SLS partners with the Global Statistical Lead to align study-level work with overall product strategy and works alongside the Study Statistician, who manages operational statistical deliverables.

Core Responsibilities

Provide statistical input and review for protocols, SAPs, TFL shells, DMC charters, SDF specifications (SDTM and ADaM), randomization specs, and other study documentation.
Participate in Clinical Study Team meetings and cross-functional study start-up activities (e.g., CRF development, database specs, IVRS review).
Lead and coordinate team meetings for SAP and TFL reviews.
Conduct and document statistical analyses for individual studies.
Perform QC of ADaM datasets and key endpoints.
Apply data-driven modeling during clinical studies.
Prepare outputs for Dose Level Review Meetings and participate in DLRMs.
Review TFLs for accuracy and consistency.
Author analysis reports including Flash Memos and CSR results sections.
Collaborate with programming teams on deliverables.
Manage timelines for statistical outputs across cross-functional teams.
Maintain familiarity with company policies, SOPs, and controlled documents.
Support internal and external audits.

Minimum Qualifications

Master’s degree in Statistics/Biostatistics or related field with high statistical content and at least 4 years of post-graduate experience in pharma or medical research, or PhD with at least 3 years of experience.
Strong written and verbal communication skills.
Deep understanding of statistical concepts in clinical study design and analysis.
Proven ability to lead statistical aspects of complex studies.
Experience developing and executing protocols and SAPs, and reviewing CSRs.
Proficiency in R programming, including simulations and statistical applications for complex study designs.
Experience with R Shiny app development and management.

Preferred Qualifications

Master’s degree with 6+ years or PhD with 5+ years of relevant experience.
End-to-end leadership of at least three clinical studies or projects.
Experience presenting and defending statistical findings in internal and external settings.
Life cycle drug development experience across pre-clinical, clinical, and post-marketing phases.
Proven ability to work cross-functionally and influence decision-making.
Experience with adaptive trial designs and Bayesian statistical methods.
Advanced R programming skills, including Shiny app development for clinical trial data.