Senior Specialist, Stat Programming

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

Requirements

• Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
• Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
• Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
• Perform programming validation to ensure quality of analysis datasets and programming outputs.
• Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
• Create TFLs shell (Data Presentation Plan) and convert TFLs to the required format for electric data submission.
• Create SDTM/ADaM datasets (including legacy study) and relevant documents for electric data submission.
• Leads / Supports the electronic submission to PMDA.
• Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
• Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
• Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
• Contribute to the creation, maintenance, and validation of standards for outputs and macros.

Benefits

• Competitive salary
• Benefits package
• Flexible work environment
• Opportunities for growth and development