Everest Clinical Research · 1 day ago
Associate Director, Statistical Programming
Bridgewater, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$170K/yr - $205K/yr
14+ 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. They are seeking an Associate Director of Statistical Programming to manage clinical trial programs, provide leadership to project teams, and ensure quality deliverables for clients.
Pharmaceutical
Responsibilities
Work with a Director, Senior Director, and/or Executive Director of Biostatistics/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
Represent the company and the Statistical Programming department in business development and client relationship management initiatives
Provide leadership and oversight to the assigned client programs/projects; ensure quality, timely, and within budget deliveries
Follow-up on the industry trends in data and programming standards and good programming working practices
Follow-up on the latest technologies, consult with clients, upper management, peers, and subordinates to evaluate, recommend, and implement improvements to the existing company standards and good working practices
Develop and maintain clinical data and statistical reporting standards in line with pharmaceutical industry standards and conventions
Coach, mentor, develop, and provide technical review, advice, and expertise to direct subordinate Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects
Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates by contributing to the performance evaluation process
When required, serve as a principal level Statistical Programmer, 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
Perform quality control (QC) review of statistical programming deliverables, including documentation, before they are released for production, delivered to clients, or submitted to regulatory agencies
These QC activities may include, but are not limited to, the following:
Review and confirm SDTM dataset specifications
Perform QC activities on SDTM datasets programmed by other Statistical Programmers and Biostatisticians
Review and confirm ADaM dataset specifications
Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians
Perform overall review of statistical tables, listings, and figures (TLFs)
Review and confirm define documents and reviewer’s guides for SDTM and ADaM datasets
When required, 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 (Plan; and the ongoing data review TLFs in accordance with the Plan), and Data Management Plan (DMP)
Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants
Qualification
Required
Must have at least a bachelor degree and preferred to have M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with at least 14 years of clinical research experience
Requires demonstrated experience and success in leading statistical programming teams in planning and implementing statistical programming project plans, leading programming teams to generate and deliver quality and timely deliverables within budget
Requires demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas
Requires demonstrated experience supporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses
Must have an in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies
Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts
Exceptional written communication and presentation skills
Preferred
Experience With Multiple Regulatory Agencies Preferred (FDA, PMDA, Etc.)
Experience with developing and delivering training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.) preferred
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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