Statistical Programmer - Clinical Operations

Posted 10 November 2021
Job type Limited
DisciplineIT/Software Development

Job description

For our customer a global company specialised in in vitro diagnostics based in Rotkreuz, we are looking for an experienced

Statistical Programmer - Clinical Operations (m/f)

Statistical Programmer will be responsible for supporting statistical programming activities for registrational and non-registrational studies. Represents Statistical Programming function on the study team and contributes towards developing, validating, and documenting software programs to meet the study needs. Depending on the project complexity, the programmer may have primary ownership of one or more studies. The programmer will be responsible for mentoring junior level programmers and may have management responsibilities.

Your tasks

  • Functions as the primary point of contact for programming related tasks for assigned study.
  • Under minimum guidance, develops and modifies SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency.
  • Develops all extraction programs to create raw datasets related to the study.
  • Develops source and analysis datasets from raw data to support the analysis of clinical trials data.
  • Responsible for creating data specifications to generate source and analysis datasets as per the study requirements.
  • Generates tables, listings, and figures to support clinical study reports and electronic submissions.
  • Develops, validates, and maintains global tools such as SAS macros that increase the efficiency of the programming team.
  • Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other ad-hoc requests.
  • Validates, documents, and archives single-use statistical software programs as per department SOPs under minimal guidance.
  • Responsible for creating submission documents necessary to support submissions to regulatory agencies in electronic format.
  • Reviews and provides input for CRFs, edit check specifications, SAP, and TLF mock-ups.

Your qualifications

  • University degree in Scientific field is preferred
  • min 3 years of experience as statistical programmer using SAS
  • Experience in this field within pharmaceutical, biotechnology, diagnostics, or medical device environment
  • Familiarity with statistical software, statistical analyses, and databases
  • Strong verbal and written communication skills
  • Experience working with R is a Plus

It is a temporary position for 1 year, with the possibility of extension afterwards.

Your application
Please apply online. For further information about the position, please contact your Kelly recruiter, Simone Mumbauer, PhD (+41 44 225 41 12).

About Kelly We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.