Study Lead Statistician - Product Facing

Job Title: Study Lead Statistician - Product Facing Job Description The Study Lead Statistician 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 Study Lead Statistician ensures operational and statistical integrity throughout the study lifecycle and supports product-level activities such as regulatory submissions and publications. This role 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. 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, including CRF development and database specifications review. • Lead and coordinate team meetings for SAP and TFL reviews. • Conduct and document statistical analyses for individual studies. • Perform quality control 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. Essential Skills • Master's degree in Statistics/Biostatistics or a related field with high statistical content and at least 4 years of post-graduate experience in pharma or medical research, or a 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. • Experience in GitHub for source code management and collaboration. Additional Skills & 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. Work Environment This is a 100% remote role, available in any time zone within the US. The position generally requires a standard 8-hour workday aligned with core business hours, with some flexibility depending on the time zone. Pay And Benefits The pay range for this position is $80.00 - $110.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits Available For This Temporary Role May Include The Following • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Oct 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.