Role Summary

The incumbent will use statistical and programming skills to analyze and interpret a broad range of preclinical study datasets. He/She will also plan and execute data management workflows to support regulatory submissions by using FDA-compliant systems.

 

Responsibilities

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 (JMP, R, 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 objectivesAct as a subject matter expert of VFPL 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) databasesPerform data aggregation to produce a data set ready for statistical analysis and/or FDA regulatory submissionsEnsure 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 reportsCoordinate 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

 

Requirement

At least Bachelor Degree or higher in Computer Science, Computer Engineering, Statistics or similar2 – 4 years of proven experience in data analytics and/or statistics, preferably in a regulated environmentExperience in analysing and processing large data sets/big data. Proven ability to automate data collection and analysis processing using computer algorithmsExperience in statistical analysis using various programs such as R or SAS and familiarity with commonly used commercial statistics software packages (eg. JMP) is preferredStrong initiative, organizational and communication skills, demonstrated capability of working on multiple projects diverse projects simultaneously Ability to complete deliverables on time and adjust priorities in a fast-paced environmentSelf-starter and highly motivated individual with ability to work independently as well as collaboratively in a team environmentGood command of spoken and written EnglishExperience working with Provantis and/or SEND is a plus