Study Lead Statistician - Product Facing
location_onLos Feliz Drive, Thousand Oaks, Ventura County, California, 91362, United States
Job Description
About the Role
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.
Equal Opportunity
Randstad is an Equal Opportunity Employer. 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.
Benefits
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.
Work location
Work model: Remote
Los Feliz Drive, Thousand Oaks, Ventura County, California, 91362, United States
Thousand Oaks, California
Key Responsibilities
- check_circleProvide statistical input and review for protocols, SAPs, and TFL shells
- check_circleParticipate in clinical study team meetings and cross-functional study start-up activities
- check_circleLead and coordinate team meetings for SAP and TFL reviews
- check_circleConduct and document statistical analyses for individual studies
- check_circlePerform QC of ADaM datasets and key endpoints
- check_circleApply data-driven modeling during clinical studies
- check_circlePrepare outputs for Dose Level Review Meetings
- check_circleReview TFLs for accuracy and consistency
- check_circleAuthor analysis reports including Flash Memos and CSR results sections
- check_circleCollaborate with programming teams on deliverables
- check_circleManage timelines for statistical outputs
- check_circleSupport internal and external audits
Requirements
- verifiedMaster's degree in Statistics/Biostatistics or related field with 4-6 years post-grad experience, OR PhD with 3-5 years experience
- verifiedDeep understanding of statistical concepts in clinical study design and analysis
- verifiedProficiency in R programming, including simulations
- verifiedExperience with R Shiny app development
Benefits & Perks
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Skills, education and keywords
Skills: r language, statistical analysis plan, statistical programming, bayesian statistics, r shiny.
Education: Master's degree in Statistics / Biostatistics or related field.