Planet Pharma · 4 hours ago
Biostatistician - Phase I (PK/Biomarker Data) - Central/Eastern Time Zone
United States
Contract
Remote
Senior Level
5+ years expPlanet 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.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Brad Phelps
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
Qualification
Required
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
Preferred
Knowledge of R preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase