Biostatistician Phase I (PK/Biomarker Data)

• **Please Note: Due to this role working alongside the UK team, we are only seeking candidates who are located reputed company EST or CST time zone*** reputed company Our reputed company, a leading Biotech company, is seeking a remote-based Biostatistician for its growing team - this role will be working alongside a UK team on a Phase I study - we're ideally targeting a person with 5+ years of experience in the clinical research industry (sponsor reputed company preferred). In reputed company, we're seeking someone with experience in R and reputed company for Biomarker and PK data. See below for other details! Skills Needed • R (for biomarker data) programming skills needed, reputed company (for PK reputed company data) • Previous PK or biomarker work • Experience in CDISC Job reputed company • Day to day: 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 reputed company 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. Requirements • 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 Apply tot his job Apply To this Job