I am recruiting for a Statistical Programmer for a multinational pharmaceutical and chemical manufacturer, they are the European leader and one of the largest globally in their field.
Statistical Programmer (Senior Level 3, Principal)
Provides statistical programming support to all our clinical trials and supervises the statistical programming activities performed internally and externally. Provides guidance to the clinical development department in the direction of clinical data standard, statistical tables, listing, and figures standards for the medical research report and for regulatory submissions.
Primary Responsibilities for role:
- Reviews the programming and data management related documents, e.g.. case report form (CRF) design, Annotation of CRF, edit checks, database structure.
- Manages and coordinates the programming activities in clinical trials to ensure the timely completion and the quality of the analysis result presentation.
- Generates and validates statistical analyses (tables, listings, and figures) using SAS and other software. Assists in the development of data analysis plan, coordinates programming and data management process with contractors/CROs, reviews the statistical deliverables, ensures the quality of the deliverables, and acts as an integral member of a clinical project team.
- Interacts regularly with other team members within clinical development department or in other departments, preventing potential issues and/or reconciling if the issues occurred.
- Maintains overall awareness in the field of statistical programming by self-training, attending training class/conferences. Maintaining current professional knowledge in broad range of clinical research.
- Performs validation and quality review of deliverables provided by internal or external resources.
- Supports the Regulatory Affairs with electronic submission to FDA by preparing the documents under CRT folder with compliance to eCTD guidelines.
- Provides scientific consulting in programming and data analysis to other departments.
- Leads the development of new initiatives for technical enhancement and process improvement (e.g.. standard Table/Listing/Figure shells).
- Assists the Head of Biometry in budget and resource planning and forecasting.
- Advanced knowledge of medical and statistical terminology.
- Advanced programming skills in SAS, including SAS macro language, data manipulation techniques, data reporting procedures (PROC REPORT, ODS, SAS/Graph), and statistical procedures (e.g., PROC FREQ, PROC UNIVARIATE, PROC GLM, PROC MIXED).
- Strong organization, analytical, verbal and written communication skills.
- Ability to multitask and prioritize work.
- Ability to implement the regulatory standards in clinical data base and clinical data tabulation.
- Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
Your knowledge and experience:
- Bachelor of Science in statistics or related field, plus 8 years of experience in programming and analyzing the clinical trial data in clinical research organization (CRO), pharmaceutical, or biotechnology industries.
If you are interested in this Principal Statistical Programmer's position please contact me through LinkedIn or directly to arrange a confidential follow up call: 00 353 1 645 5222, Mobile: 00 353(0)87 621 4254, email@example.com