Kaye/Bassman International · 3 days ago
Senior/Executive Director of Biostatistics
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Responsibilities
Team oversight in budget and hiring
Responsible for randomization specifications, QC the dummy codes, and signoff.
Collaborate with safety, medical, data management and clinical operations to align statistical analysis plans with data collection procedures and forms.
Facilitate and participate in cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM/ADaM datasets, etc.
Provide scientifically rigorous statistical input and review of clinical protocols, draft a statistical analysis plan, interpretation of statistical results and scientific publications.
Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs.
Develop strategies to address health authorities’ inquiries pertaining to biostatistics.
Provide programming support across development to support delivery of summarized tabular/graphic analyses for inclusion in publications and external scientific meetings and multi-dimensional nonclinical and clinical data analyses.
Qualification
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Required
Master or Ph.D. in Statistics/Biostatistics/mathematics with 15+ years of directly relevant experience required.
Good SAS programming skills are required.
Experience required in oncology therapeutic area. Including NDA filing
Prior experience submitting a BLA or NDA filing in multiple assets.
Able to examine relevant data and quickly develop an analysis plan that will answer key business and regulatory questions.
Understanding of clinical or advanced statistics such as regression models, time-to-event analysis, adaptive design, exploratory data analysis methodology in general, K statistics, and the Bayesian statistics.
Experience in working with clinical database software and data structures, especially Medidata RAVE preferred.
Knowledge of and experience with CDISC standards and validation processes required with GCP, ICH and FDA requirements.
Preferred
Management experience in leading team up till 5 people
Collaborative and educational
Company
Kaye/Bassman International
Kaye/Bassman International is a staffing and recruiting company that offers executive search and professional recruitment.
Funding
Current Stage
Growth StageRecent News
2024-11-16
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