Everest Clinical Research · 1 day ago
Director, Biostatistics
United States
Full-time
Remote
Director/Executive
$190K/yr - $230K/yr
12+ 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 Director of Biostatistics to provide leadership, resolve complex operational problems, and ensure high-quality deliverables in clinical trials.
Pharmaceutical
Responsibilities
Provide leadership and expertise in resolving complex operational and technical problems in support of division/company objectives and projects, or as a resource to others
Maintain expertise in industry norms, trends across biostatistics, statistical programming, and regulatory requirements
Provide supervision to ongoing projects by applying management skills, regulatory standards and requirements, and quality management to ensure quality and timely deliverables
Build and maintain relationships with assigned clients to ensure biometrics services are well represented and that communication with the client and the functional teams are clear
Represent biostatistics and statistical programming for the company in external business development, regulatory or industry consortiums
Represent biostatistics and statistical programming functional service groups in external and internal audits, as well as qualification/maintenance audits for vendors contracted by Everest
Monitor and assess the progress status of ongoing projects
Ensure high quality standards, on time delivery within budget for all stages of the clinical trials – from the trial design, protocol development, statistical analysis planning and execution, to the writing of statistical sections of the Clinical Study Reports or the generation of publications of trial results
Provide leadership and expertise in day-to-day statistical operations and development of statistical methodologies to solve practical statistical problems
Serve as a principal level biostatistician, working effectively with interdisciplinary teams to contribute to drug development at the study and drug compound levels
Provide statistical consultation to trial medical/clinical personnel when required
Participate in development of study concepts and study protocols
Lead statistical and programming teams on assigned projects
Plan and manage resources, timelines, and quality of statistical and programming deliverables
Perform planned, ad hoc, and/or exploratory statistical analyses
Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports, publications, abstracts, posters, presentations, etc
Review statistical documents generated by others
Perform independent validation of statistical results generated by others and perform third level Quality Control review on statistical and programming deliverables before they are released to the clients
Interact with regulatory agencies and support client in New Drug Applications/Biologic License Applications
Mentor and supervise direct and indirect subordinates
Perform semi-annual and annual performance reviews and prepare developmental plans for direct subordinates and indirect subordinates, where appropriate, through contributing to the performance evaluation process
Plan and manage resourcing plans by working with the Project Management group in forecasting resource needs relative to the roles of the personnel
Proactively and continually update the plan with changes to demand, and identify/solution resourcing gaps or overage
Participate in recruiting and staffing for responsible functional area, as well as coaching, mentoring, and developing staff members
Contribute to the company’s management team function and activities
Qualification
Required
A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 12 years of relevant experience or a Master's degree in these fields with at least 15 years of relevant experience and a minimum of 4 years managing people, with demonstrated exceptional ability and performance
Significant contribution, and/or outstanding/sustained performance may be used in lieu of the requirement on the number of years of relevant experience
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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