Everest Clinical Research · 17 hours ago
Biostatistician II
Bridgewater, NJ
Full-time
Hybrid
Mid, Senior Level
$90K/yr - $120K/yr
4+ years expEverest Clinical Research is a full-service contract research organization providing clinical research services to the pharmaceutical, biotechnology, and medical device industries. They are seeking a Biostatistician II to apply expertise in statistical, programming, and data management methods to support decision-making and enhance customer satisfaction.
Pharmaceutical
Responsibilities
Lead efforts in resolving day to day work related issues and problems, improving efficiency, quality, and productivity of the operation; enhancing customer relationship and improving customer satisfaction level on our services. These efforts may include, but are not limited to, the following:
Research and development of statistical methodologies
Investigate and implement new technologies, processes and procedures
Participate in developing and executing marketing strategies and plans (trade shows, publications/presentations, corporate website design and maintenance, meeting with existing and new clients)
Participate in developing and executing customer relationship management plans
Participate in business development and maintenance activities
Perform review for clinical study protocols and statistical, programming, and data management documents generated by others
Lead assigned projects by applying project management skills, statistical, programming, and data management techniques to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products
Plan, develop and monitor timelines for statistical, programming, and data management activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical, programming, and data management resource needs and manage the assigned resources
Provide statistical and data management input into protocol development. Write Statistical Analysis Plans for assigned projects. Oversee IVRS and web-based patient randomization processes for assigned projects
Oversee the development of Data Management Plans (DMPs) for assigned projects
Provide statistical input into Case Report Forms (CRF) design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRFs
Provide statistical and programming input into database design for assigned projects, and oversee efforts in development, validation and testing of the study databases
Participate in Study Manual Development, and in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical, programming, and data management questions/concerns from the meeting participants. Train site personnel on data management requirements and procedures
Oversee data management and programming activities for assigned projects. Serve as primary contact between medical/clinical and data management in data related issues
Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer
Perform statistical data analyses. Write statistical and data management sections of the joint medical and statistical Study Reports for assigned projects
With assistance from the Archivist, archive study documentation upon the completion of final Clinical Study Reports
Participate in evaluating the performance of assigned project personnel
Follow up on the development and implementation of new statistical, programming, and data management methodologies which will improve current/future decision making or divisional/corporate business processes, and on the statistical/data management related regulatory requirements and practices
Participate in the development and maintenance of, and adhere to divisional SOPs and guidelines
Participate in the development and maintenance of, and adhere to therapeutic area specific standards and conventions
Participate in the development and maintenance of, and adhere to corporate policies and SOPs
Plan and carry out professional development
Qualification
Required
A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 2 years relevant experience or a Master's degree plus 4 to 5 years relevant experience with demonstrated ability and sustained 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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