Everest Clinical Research · 3 days ago
Associate Director, Biostatistics
Bridgewater, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$175K/yr - $210K/yr
10+ years expEverest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. The Associate Director, Biostatistics will manage clinical trial programs, provide leadership to project teams, and ensure sound statistical methodologies in study design and analysis.
Pharmaceutical
Responsibilities
Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics 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
Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects
Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process
Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables
Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting
Provide statistical input in protocol design and development
Participate in the writing of trial protocols and research proposals
Serve as a principal level 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 not limited to the following: electronic Case Report Forms (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 (DMP)
Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs)
Perform peer review of SAPs and other technical documents written by others
Perform hands-on statistical analysis and modeling; maintain 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 (QC) review on statistical deliverables before they are released to the clients
Review and confirm ADaM dataset specifications
Perform QC 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
Act as a consultant to less experienced Biostatisticians
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 generation of performance 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
Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required
Participate and/or assist in statistical and programming project budget planning, tracking, and reporting
Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders
Qualification
Required
A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience
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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