Priya Mukherjee at CK Clinical is recruiting for a Principal Statistical Programmer to lead and support worldwide statistical programming activities for an assigned project area, for clinical trials who responsibility resides in Development.
As Principal Statistical Programmer, you will lead all statistical programming activities for multiple clinical trials or submissions. You will also set up and oversee a clinical project or trial, and provide programming support to enable delivery of high quality statistical programming work product. In addition, you will generate datasets (SDTM and ADaM) and tables, figures, listings, and documentation for clinical study reports, ad hoc requests, and regulatory submissions.
- Lead statistical programming activities for assigned clinical trials and submissions and support the global team of Statistical Programmers. Coordinate and provide input for assigned project and trial teams on timelines and work product required to deliver high quality statistical programming services.
- Program, validate, maintain, and document statistical analysis programs for clinical trials on the basis of the Statistical Analysis Plan and of other trial documents following the standard company’s operating procedures and working documents.
- Ensure that submission and trial datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within the organisation.
- *Ensure that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following Global Statistical Programming procedures and standards. Assist with developing specification documentation for datasets (SDTM andADaM), pooled datasets, tables, figures, listings, and associated metadata.
The ideal candidate:
To be considered for this Principal Statistical Programmer role, you will hold a BSc in a Scientific discipline (OR Equivalent) together with proven Statistical Programming experience within the Biotechnology and/or Pharmaceutical Industry, including clinical research organizations.
You will have excellent SAS Programming skills, including DATA step, SQL and macro development, Output Delivery System (ODS), to solve complex programming tasks, together with excellent knowledge of SDTM and ADaM programming requirements and practices, in order to develop statistical programming tools to efficiently develop study specific SDTM and ADaM data sets, statistical programming systems and standard macros for efficient programming.
You should also hold excellent knowledge of Clinical Trials Design and Analysis, including a comprehensive understanding of drug Development Phases, Clinical Trials Designs, Efficacy Endpoints and Assessments and Safety End points andAssessments.
How to apply:
For more information or to apply for this Principal Statistical Programmer role, please contact Priya Mukherjee at CK Clinical on 01438 870028 or email firstname.lastname@example.org.