Position Title:  Statistician

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 objectives
• Act 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) databases
• Perform data aggregation 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

Requirement

• At least Bachelor Degree or higher in Computer Science, Computer Engineering, Statistics or similar
• 2 – 4 years of proven experience in data analytics and/or statistics, preferably in a regulated environment
• Experience in analysing and processing large data sets/big data. Proven ability to automate data collection and analysis processing using computer algorithms
• Experience in statistical analysis using various programs such as R or SAS and familiarity with commonly used commercial statistics software packages (eg. JMP) is preferred
• Strong 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 environment
• Self-starter and highly motivated individual with ability to work independently as well as collaboratively in a team environment
• Good command of spoken and written English
• Experience working with Provantis and/or SEND is a plus