Study Lead Statistician - Product Facing

Study Lead Statistician (SLS) – Product Facing Location: Fully Remote (US Mainland; must align to Pacific Time) Duration: 12-month contract, possible extension/temp-to-hire Hours: Monday–Friday, 8 AM – 5 PM PT Pay Rate: Up to $113/hour SUMMARY The Study Lead Statistician (SLS) for product-facing work leads statistical activities for clinical studies and supports product-level deliverables. This role collaborates closely with cross-functional teams to ensure studies are well-designed, statistically sound, compliant with regulatory standards, and aligned with internal Company 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. Note: Candidates must demonstrate 3–5+ years of pharmaceutical industry experience, including clinical trial work, and hold a postgraduate degree in statistics or a related field. Candidates with SAS-only backgrounds or vague, nonspecific resumes will not be considered. 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 (DLRMs) and actively participate in discussions. • 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 a related field with strong statistical content and at least 4 years of post-graduate experience in the pharmaceutical industry 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, 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.