Everest Clinical Research · 2 days ago
Principal Statistical Programmer (Remote)
United States
Full-time
Remote
Lead/Staff
$125K/yr - $155K/yr
9+ 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 Statistical Programmer to lead complex statistical programming projects, coordinate study teams, and ensure quality deliverables while adhering to industry standards.
Pharmaceutical
Responsibilities
Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems
Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables
Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability
Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements
Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc
Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others
Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others
Perform 3rd level QC review on programming deliverables before their release to the clients
Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc
May lead programming efforts for drug development programs or for assigned client clusters
Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming
Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents
May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses
Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices
Participate in statistical programming project bidding or bid defense meetings
Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors
Qualification
Required
M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields
10 (M.Sc., M.A.)/9 (Ph.D.) years' related experience
An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies
Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented
Knowledge of clinical trial regulatory and ICH requirements
Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies
Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations
Must have sound technical judgment and experience in process design and implementation in relevant areas
Strong leadership and drive to achieve goals will be required
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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