Senior Statistical Programmer

  • Contract
  • Remote

SimulStat

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Remote, 6 month contract with potential to extend

SUMMARY:

The contract senior statistical programmer performs statistical analysis on data related to product development in a research and development environment. Uses statistical software (SAS, R, etc.) and/or data visualization tools (Tableau) to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests.

Creates datasets in a standard format (i.e., SDTM), analysis datasets (i.e., ADAM), assesses quality of data analysis programs, and develops automated analysis tools, where appropriate. Develops programs to assist with data review such as edit checks and custom listings.

May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Independently develops SAS or other programs, and specifications (e.g., SDTM, ADaM), for use in study or other analyses, such as Integrated Safety Summaries.
  • May serve as a lead or support programmer
  • If the lead programmer on studies, works with clinical data management staff and biostatisticians to coordinate, and schedule data transfers and the delivery of required outputs. Responsible for helping to identify when additional programming resources are needed for a project, communicating with their supervisor to arrange for those resources, and coordinating and overseeing other statistical programmers’ work on the project as needed.
  • Oversees the development of datasets in SDTM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
  • Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs).
  • Independently verifies other programmer’s results.
  • Adheres to FDA regulations regarding training records, guidelines, and SOPs.
  • Adheres to company SOPs and department guidelines.
  • Produces study datasets and programs that meet CDISC standards and regulatory requirements.
  • Supports Ad-hoc requests as needed.
  • Works on multiple tasks at the same time and prioritize tasks to meet business needs.
  • Trouble-shoots technical and project issues.
  • Communicates with outside departments and/or groups.

EDUCATION/EXPERIENCE/SKILLS:

Education:

  • BS/BA degree in related discipline and a minimum of seven years of related experience; or,
  • MS/MA degree in related discipline and a minimum of five years of related experience; or,
  • PhD in related discipline and zero of more years of related experience; or,

Experience:

  • Typically requires at least seven years of experience in statistical programming with clinical data and SAS.
  • Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros.
  • UNIX, S-Plus, R, Tableau, CDISC, and SAS/GRAPH experience desirable.
  • Ability to communicate verbally and in writing in a clear and timely manner.
  • Experience in Biotech/Pharmaceutical industry preferred.

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