Study Lead Statistician - Product Facing

Job Summary 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 Company's 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. location: Telecommute job type: Contract salary: $95.00 - 113.05 per hour work hours: 9 to 5 education: Masters 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. Qualifications Minimum Qualifications • Masters 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 • Masters 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. skills: CSR, ADaM, R Language, SDTM, Statistical Analysis Plan, R Shiny, Clinical Study Support and Data Dissemination, Clinical Study Report (CSR), Clinical Study Protocol Summaries Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. u00006475229