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

Note: The job is a remote job and is open to candidates in USA. Planet Pharma 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 methods, 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 quality and timeliness of corresponding statistical deliverables
• Independently provides statistical advice related 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 Form, Data Validation Plans, tables listings and figure (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data)
• Under the supervision of an experienced statistician, may support more complex 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 - standard output generation - 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. Close partners, the statistician and programmer communicate frequently and update each other and other team members on progress of individual deliverables Skills
• PhD or M.S in Biostatistics, Statistics or related scientific field
• 3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
• Good knowledge and skills in SAS required, knowledge of R preferred
• Good understanding of medical literature, clinical, regulatory, and commercial landscape
• Ability to understand, implement, and explain complex statistical methodology
• 5+ years of experience in the clinical research industry (sponsor side preferred)
• R (for biomarker data) programming skills needed, SAS (for PK related data)
• Previous PK or biomarker work
• Experience in CDISC
• Knowledge of R preferred Company Overview
• Planet Pharma 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
• Planet Pharma has a track 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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