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Principal Statistical Programmer

Principal Statistical Programmer

cGxPServeSan Diego, CA, United States
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Responsibilities :

  • Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
  • Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.
  • Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts and other clinical publications; support systems to produce electronic regulatory submissions.
  • Assist in establishing standardized programming procedures and work instructions.
  • Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation / compliance activities.
  • Develop and maintain clinical processing workflow systems.
  • Assist in the development of client proposal documents.
  • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
  • Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.
  • Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.
  • Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.)
  • Records handling (e.g., Chapter 21 of the US Code of Federal Regulation Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards).
  • Assist in updating / writing PROMETRIKA standard operating procedures (SOPs).
  • Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
  • Develop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
  • Create define.xml files from metadata files for SDTM and ADaM.
  • Convert data received in other formats to SAS datasets.

Requirements :

  • Must have expertise in SAS / BASE, SAS / STAT, and knowledge of SAS / CONNECT, SAS / ACCESS, SAS / MACRO, SAS / GRAPH, SQL, and ODS.
  • Knowledge of SDTM, ADaM, FDA and ICH guidance
  • Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems.
  • Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.
  • Consistent experience as a lead statistical programmer on several concurrent projects.
  • Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
  • Strong mentoring skills as shown by leadership of projects and if applicable, junior team members.
  • Excellent analytical skills.
  • Proven ability to learn new systems and function in an evolving technical environment.
  • Ability to negotiate and influence to achieve results.
  • Good presentation skills.
  • Good business awareness / business development skills (including financial awareness).
  • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
  • Work effectively in a quality-focused environment.
  • Knowledge of other programming languages and database management software packages is a plus.
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    Principal • San Diego, CA, United States