Statistician

The Job Define the optimal statistical tests to analyze and evaluate the data sets. Contribute to the statistical analysis component of the study plan and then conduct the statistical evaluation accordingly (R, SAS or other statistical software package) to produce a statistics report. Ensure statistics SOPs (work instructions) are current, and are kept updated to aligned with company objectives. Act as a subject matter expert of Standard Exchange Nonclinical Data (SEND) terminology and formatting, and ensure that the systems for data capture and raw data output are in accordance to current standards. Effectively manage the Non-Clinical Data Management (NCDM) databases. Perform aggregation of raw data, data cleaning, and identification of outliers or missing data points to produce a data set ready for statistical analysis and/or FDA regulatory submissions. Ensure internal documentation and procedural practices current and updated, and aligned with the FDA preferred data submission formats (SEND). Interaction with different departments to ensure data is collected in appropriate format, and with the proper terminology. Provide expertise to the scientists and study directors in areas of data collection and analysis, and provide statistical reports. Coordinate and document the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from external laboratories or CRO's) including a seamless process to encompass this data for regulatory submissions according to the relevant external and internal guidelines.