Everest Clinical Research · 2 days ago
Principal Biostatistician (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
$140K/yr - $175K/yr
7+ years expEverest Clinical Research is a full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Principal Biostatistician to manage clinical trial programs, provide statistical oversight, and mentor junior staff while ensuring compliance with regulatory requirements.
Pharmaceutical
Responsibilities
Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects
Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting
Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects
Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals
Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels
Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan
Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others
Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements
Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients
Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians
Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations
Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions
Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g., CDISC)
Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents
Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants
Qualification
Required
A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience or a Master's degree in these fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance
Company
Everest Clinical Research
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields
501-1000 employees
H1B Sponsorship
Everest Clinical Research 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
2025 (4)
2024 (4)
2023 (4)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$0.1MKey Investors
FedDev
2020-12-07Acquired
2019-08-18Grant· $0.1M
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