K3-Innovations, Inc. · 5 hours ago
PRINCIPAL BIOSTATISTICIAN
United States
Full-time
Remote
Lead/Staff
10+ years exp
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Hiring Manager
Ilene Brooks
Insider Connection @K3-Innovations, Inc.
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Responsibilities
Provides high quality statistical input, contributions, and deliverables in a timely manner, and supports the biostatistics lead on a program
Works independently with minimal supervision on multiple studies and/or projects in a flexible and agile manner, often under tight timelines, adapting as organizational needs and priorities change
Proactively identifies, communicates, escalates and resolves relevant issues and areas of concern, working closely with study/project teams and Biostatistics line management
Calculates sample sizes/power for proposed studies, for alternative designs, and evaluates the advantages/disadvantages and timelines for various scenarios
Ensures that proposed statistical analyses adequately and appropriately address study and scientific objectives and that study design and data collection support conducting the proposed statistical analyses
Reviews statistical sections of protocols and clinical study reports, randomization specifications/schedules, statistical analysis plans, table/figure/listing shells, analysis dataset specifications, statistical aspects of publications (abstracts, presentations, and manuscripts), and statistical requirements for data collection within a project
Reviews case report forms, edit check specifications, vendor data specifications, and other data management related documents to ensure data collected are appropriate to meet scientific and statistical objectives
Responsible for supporting the biostatistics lead in responding to regulatory authority questions and in preparations for regulatory authority meetings
Proactively develops knowledge and expertise beyond biostatistics by researching relevant medical literature and regulatory precedent to develop an understanding of the clinical, regulatory, and commercial context for a product’s development
Qualification
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Required
Master’s degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 10 years of relevant experience in the pharmaceutical/biotechnology industry
Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development
Knowledge of pharmaceutical/biotech industry processes and procedures
Knowledge of regulatory guidelines and requirements, including those from ICH, FDA, and EMA/CHMP
Substantial knowledge of and experience with SAS programming, including: Clinical Data Interchange Standards Consortium (CDISC) standards for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets; Identification, investigation, and communication of data issues affecting statistical analyses; and Details of SAS procedures needed to execute statistical analyses
Proficiency in nQuery/EAST sample size software packages
Ability to oversee programming work performed by programming staff or vendors
Excellent verbal and written communication skills and presentation skills
Strong interpersonal skills, including ability to work well in a team environment and ability to interact with individuals at all levels of the organization
Attentive to detail
Demonstrated proficiency in project planning, management, and prioritization and in proactively anticipating, identifying, and proposing solutions to complex issues and problems
Company
K3-Innovations, Inc.
At K3-Innovations, we are passionate about delivering exceptional clinical research services to the bio/pharmaceutical and medical device industries.
51-200 employees
H1B Sponsorship
K3-Innovations, Inc. 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 (5)
2021 (2)
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase
