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Principal Statistical Programmer

Principal Statistical Programmer

Katalyst Healthcares & Life Sciences

San Francisco, CA

Other

Posted 15 days ago

Job description

Responsibilities:
  • 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.
  • 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.

Requirements:
  • M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
  • 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.
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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Principal Statistical Programmer?

A: To succeed as a Principal Statistical Programmer, one should possess strong technical skills in programming languages such as R, Python, or SAS, as well as expertise in statistical analysis, data visualization, and data management. Additionally, effective communication, leadership, and problem-solving skills are crucial for collaborating with cross-functional teams, mentoring junior programmers, and navigating complex data-driven projects. By combining technical expertise with strong soft skills, a Principal Statistical Programmer can drive data-driven insights, lead high-performing teams, and contribute to the development of innovative statistical solutions.

Q: What is the career path for a Principal Statistical Programmer?

A: A Principal Statistical Programmer's career path typically begins with entry-level roles such as Statistical Programmer or Biostatistician, where they develop programming skills in languages like R, Python, or SAS. As they gain experience, they progress to mid-level roles like Senior Statistical Programmer or Lead Biostatistician, where they oversee project teams, mentor junior staff, and contribute to methodological development. Ultimately, they can advance to senior roles like Principal Statistical Programmer or Director of Biostatistics, where they lead large-scale projects, drive innovation, and collaborate with cross-functional teams to inform business decisions.

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Katalyst Healthcares & Life Sciences job posting for a Principal Statistical Programmer in San Francisco, CA with a salary of $86 to $115 Hourly with a map of San Francisco location.