Posted on Nov 14, 2021 by ITech Consult
Statistical Programmer - SAS, R, SAS, pharmaceutical, biotechnology, diagnostics, or medical device
For our client in the Pharma industry based in Rotkreuz we are looking for a Statistical Programmer.
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. In this role, programmer will be accountable for the implementation and delivery of complete and accurate data and reports to support regulatory submissions. Organizes and facilitates programming tasks to ensure timely study deliverables. 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.
The ideal candidate for this position is someone with a scientific education and experience with clinical programming using SAS (R is a plus). Some trainings will be provided in the role therefore we are open to more junior (minimum 3 years still) profile. The team is also open to more senior profiles. The role is opened to replace an internal team member.
Areas of responsibility:
* 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.
* Leads data discrepancy process within a study.
* Responsible for creating submission documents necessary to support submissions to regulatory agencies in electronic format.
* Reviews outputs to ensure consistency across programs within study.
* Reviews and provides input for CRFs, edit check specifications, SAP, and TLF mock-ups.
* Review, maintain, and approve study documents per standard procedures.
* Uses discretion and independent judgment to consider and determine appropriate solutions/actions to a range of problems.
* Participate in the development and/or maintenance of departmental procedures and standards.
Professional and technical requirements:
* Minimum Bachelor, Preference on Master in Scientific field
* 2-5 years professional 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
Reference no: 920843 AD
Role: Statistical Programmer
Industry: Pharmaceutical industry
Location: Rotkreuz, Switzerland
Start date: ASAP
Duration: 12 months contract, with possible extension
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.