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Senior/Principal Statistical Programmer

Company: Spectrum Pharmaceuticals Inc.
Location: Irvine
Posted on: July 15, 2019

Job Description:

Summary: This position is responsible for leading Statistical Programming activities including hands-on programming of statistical analysis and datasets. The person is responsible for statistical programming deliverables of Phase I-IV clinical trials and to provide input to specifications to ensure that the clinical/statistical programming elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.

Responsibilities:





  • Represent Clinical and Statistical Programming in meetings with internal cross-functional and external customers

  • Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies

  • Work closely with statisticians, and medical monitors for pre-specified and ad hoc study data analyses; work with data management personnel to identify data issues

  • Generate SDTM datasets, ADaM datasets, tables, listings, figures and project specific macros and formats; import/export external data from/to other platforms and other software packages

  • Prepare data specifications describing all datasets and variables

  • Perform data checks as needed, to ensure integrity and correctness of data displays, prepare documentation for programs

  • Program customized data displays, (including data listings, summary tables and routine graphics) in accordance with approved statistical analysis plan and shell displays for clinical research studies. Code is to be written using Base SAS programs, SAS procedures, or standardized macros. Perform data checks as needed to understand structure and content of data.

  • Perform external data loads, i.e., labs, ECGs, etc., as needed and perform data reconciliations

  • Develop and validate technical programming specifications for transforming raw data using SDTM standards

  • Review CRFs/eCRFS, edit check specifications and table mock-ups; maintain and approve protocol specific documents as necessary


    Skills, Education and Experience:

    • 4 year degree in life Science, Computer Science or equivalent; MS preferred

    • 6-8 years statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.

    • Ability to clearly communicate processes and standards with management and team members.

    • Knowledge of clinical database design, specifically electronic data capture

    • proficiency in SDTM models and experience transforming raw data into those standards.

    • Knowledge of creating all necessary files, documents and analyses to support electronic submissions In eCTDformat

    • Knowledge of:





      • Data Management and Pharmacovigilance processes in clinical trials.

      • Relational databases.

      • Good clinical practices.

      • Good programming practices.

      • 21CFR Part 11 standards.

      • Integrated summary safety/efficacy analyses for regulatory filing.

      • Safety data and coding dictionaries




        Position location and/or Territory and Travel

        • Position is located in Irvine, CA.


          Required Skills

          Required Experience

          Job Location

          Irvine, US-CA

Keywords: Spectrum Pharmaceuticals Inc., Irvine , Senior/Principal Statistical Programmer, IT / Software / Systems , Irvine, California

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