Everest Clinical Research · 3 hours ago
Senior Manager, Statistical Programming
United States
Full-time
Remote
Senior Level, Lead/Staff
$150K/yr - $190K/yr
9+ 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 Senior Manager, Statistical Programming will lead programming efforts, mentor team members, and ensure compliance with industry standards while managing complex statistical programming projects.
Pharmaceutical
Responsibilities
Coach, mentor, develop, 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 develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process
Participate in the development and maintenance of standards for database design by defining standard database modules, variable names, attributes, and associated data validation/logical checks
Participate in the development and maintenance of standards for SAS datasets of clinical trial data, including but not limited to, raw and derived datasets from Everest databases or acquired from sponsors or 3rd party vendors. The dataset standards will address standardization in dataset structure and names, variable attributes and definitions, documentation such as files of dataset define.doc
Perform a leadership role in statistical programming and reporting with focuses on planning and execution of programming tasks involving standardized summary tables, listings, and graphs using established standard mockups and SAS programs/macros. When required this effort will cover all standard and non-standard subject data listings and graphs, as well as SAS logical checks and batch editing of clinical trial data. This leadership role will involve in the planning, leading, assessing, project management and reporting the progress status of the assigned projects, and contributing to the performance evaluation of project team members
Lead programming efforts for assigned client clusters
Provide mentorship and technical supervision to the statistical programming project team members of responsible projects. Monitor the compliance of and adherence to the established standards by reviewing the programs and outputs from the project team members assigned to the responsible projects
Follow up on the industry trends in data and programming standardization, 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
Participate in the development of statistical programming SOPs, guidelines, and good working practices
Assist in recruiting and developing of statistical programmers
Provide initial orientation training to Statistical Programmers and Biostatisticians
Lead the efforts to plan and execute archiving of the statistical programming information upon completion of the project and transfer of the archives to the sponsor
Perform the job accountabilities of a Principal Statistical Programmer, and assist statistical programming management in managing statistical programming projects, interacting with clients, and providing day to day close supervision of statistical project team members
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
Minimum 9 years' experience with 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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