– Long-term remote FSP
– West-coast based (pacific or mountain time), start date January 6, 2020
* Min. 12 (ideally 15) years of statistical programming experience.
* Prior experience leading/managing projects/people is critical
* Must have extensive experience with Kaplan-Meierplots (Oncology)
* Must have great communication skills, ability to work independently
Responsibilities will include, but are not limited to, the following:
* Providing programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells;
* Writing SAS programs to generate derived analysis datasets, perform analysis, and TFLs, performing ad hoc flexible and rapid programming arising from questions generated from planned analyses and results;
* Performing programming validation to ensure the quality of analysis datasets and programming outputs; ensuring consistency and adherence to standards within the project;
* Creating Define Files and converting TFLs to the required format for eSubmission,
* Providing programming support for the preparation of integrated reports, submissions and post-submission activities;
* Converting, verifying and integrating multiple sources of incoming data for the creation of analysis datasets; serving as a coordinator when multiple programming resources (e.g. CROs or contractors) are used; and
* Contributing to the creation, maintenance, and validation of standards for outputs and macros.