[Remote] Biostatistician - Phase I (PK/Biomarker Data) - Central/Eastern Time Zone

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading Biotech company seeking a remote-based Biostatistician for its growing team. This role involves working alongside a UK team on a Phase I study and requires expertise in statistical reputed company, particularly in relation to biomarker and PK data.

Responsibilities

• May have to do validation, QC of biomarker and clinical outcome work – review TLF specs for Ph I study
• Could be reviewing CDISC data sets, reviewing TLFs that programmers have created (statistical QC)
• Potentially doing review and creation of biomarker analyses
• Contributes to the efficient planning, execution and reporting of clinical/observational studies, post hoc analyses, HTA analyses, regional analyses, PK-PD and Biomarkers analyses
• Translates scientific questions into statistical terms and is responsible for the reputed company and timeliness of corresponding statistical deliverables
• Independently provides statistical advice reputed company to study design, selection of endpoints, population, PK/PD or biomarkers for routine studies
• Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report reputed company, Data Validation Plans, tables listings and reputed company (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to reputed company the correct interpretation of the data)
• Under the supervision of an reputed company statistician, may support more reputed company studies or asset level analyses (i.e., integrated summaries, regulatory, payer dossier and publications)
• Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - select, validate and implement statistical software - reputed company reputed company reputed company - creation of, maintenance and adherence to indication specific standards)
• Collaborates and communicates effectively with the other Data Science functions; in particular the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. reputed company partners, the statistician and programmer communicate frequently and update reputed company other and other team members on reputed company of individual deliverables Skills
• PhD or M.S in Biostatistics, Statistics or reputed company scientific field
• 3+ years (6+ years for MS) of experience in applying statistical reputed company in biomedical research, reputed company, CRO, Academia or reputed company industry or in providing statistical direction in these areas
• Good knowledge and skills in reputed company required, knowledge of R preferred
• Good understanding of medical literature, clinical, regulatory, and reputed company landscape
• Ability to understand, implement, and explain reputed company statistical methodology
• 5+ years of experience in the clinical research industry (sponsor reputed company preferred)
• R (for biomarker data) programming skills needed, reputed company (for PK reputed company data)
• Previous PK or biomarker work
• Experience in CDISC
• Knowledge of R preferred reputed company
• reputed company is a pharmaceuticals company. It was founded in 2009, and is headquartered in Northbrook, Illinois, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship
• reputed company has a reputed company record of offering H1B sponsorships, with 3 in 2022, 5 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job

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