Clinical Data Associate - II

Description:

Works collaboratively with Process Engineers and Statisticians in Global Manufacturing Sciences and Technology (GMSAT) Statistical Sciences & Analytics (SS&A) team to meet project deliverables and timelines to author and approve Continued Process Verification (CPV) related reports such as Process Monitoring Reports (PMR) and Annual Product Reviews (APR). Performs Data Verification requirements per Kites Standard Operating Procedures (SOP) e.g. reproduces all CPV statistical output using JMP scripts reviews documents for data and information accuracy notifies author of errors and ensures corrections are made prior to approval and completes sign offs in QMS. Assists with report authoring by populating graphs tables and attachments in Word templates and identifying deviations using QMS. Extracts and transforms data from excel or databases as needed. Attends and participates in regular meetings to review and track report progress. Assists with the preparations for bimonthly Process Monitoring Tier 4 meetings attends meetings and takes meeting minutes. Must be able to effectively communicate and possess good problem solving as well as people/project leadership skills.

Requirements and Preferred Qualifications:
BS degree with 5 years or MS degree with 3 years of technical experience in biologics / biopharma hightech industry
o BS or MS degree in Data Analytics Data Science Applied Statistics or Applied Math preferred
Proficient in SQL SAS or equivalent for data extraction and transcription
Proficient in JMP SAS or equivalent for statistical analyses and familiar with Statistical Quality Control techniques e.g. SPC and Process Capability.
Knowledge of python code for report generation.
Proficient in Microsoft Word and Excel
Exceptional attention to detail with the ability to meet aggressive deadlines
Good communication and documentation skills ability to network and interact with manufacturing sites in different time zones
Knowledge of data management and ability to manage project and prioritize multiple projects
Familiarity with a Quality Management System (QMS) and how it is used in biotech

Project Work:
1. Report Authoring:
a. PMRs: prepopulate tables (including deviation tables) and graphs
b. Control Limits: Manage and prepare data compute and propose statistical limits and assist with report authoring
2. Report Verification:
a. PMRs: raw data figure and table formats rerun all charts check control limits tables statistics summaries and deviations against original data sources and metadata files.
b. APRs: raw data figure and table formats rerun all charts check control limits tables statistics summaries and deviations against original data sources and metadata files.
c. Control limits: verify analytics approaches uses rerun all analysis verify updated limits.
3. Tier 4 Meetings:
a. Take minutes
b. Crosssite comparison prep: prepare data generate outputs from JMP scripts and update the slide deck.