Clinical Data Associate - II

ATR International; Santa Monica (CA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Voluntary Dental Insurance

Vision Insurance

Life Insurance

Supplemental Income

Sick Leave

Job summary

An established industry player is seeking a detail-oriented professional to join their team in biotechnology research and engineering services. This role involves collaborating with engineers and statisticians to produce critical reports, ensuring data accuracy, and participating in project meetings. The ideal candidate will have a strong background in data analytics and statistical analysis, with proficiency in tools like SQL and JMP. Join a dynamic environment where your contributions will directly impact project success and help drive innovation in the biopharma sector. If you are passionate about data and have a knack for problem-solving, this opportunity is perfect for you.

Qualifications

• 5 years of experience in biologics or biopharma, or 3 years with an MS degree.
• Proficient in SQL, JMP, and SAS for data extraction and statistical analysis.

Responsibilities

• Collaborate with engineers and statisticians to meet project deliverables.
• Author and approve Continued Process Verification (CPV) related reports.

Skills

Data Verification

Problem Solving

Communication Skills

Project Leadership

Attention to Detail

Education

BS degree in Biologics/Biopharma

MS degree in Data Analytics/Data Science

Tools

SQL

SAS

JMP

Microsoft Word

Microsoft Excel

Python

Job 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 Kite’s 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 bi-monthly 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.

Project Work:

1. Report Authoring:
   1. PMRs: pre-populate tables (including deviation tables) and graphs
   2. Control Limits: Manage and prepare data, compute and propose statistical limits and assist with report authoring
   3. APRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
   4. Control limits: verify analytics approaches uses, re-run all analysis, verify updated limits.
2. Meeting Participation:
   1. Take minutes
   2. Cross-site comparison prep: prepare data, generate outputs from JMP scripts and update the slide deck.

Requirements and Preferred Qualifications:

• BS degree with 5 years or MS degree with 3 years of technical experience in biologics / biopharma, high-tech industry
• 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

Benefits include:

• MEC/ACP Medical
• Voluntary Dental, Vision, Life, Supplemental Income
• sick leave as required by state/county

Seniority level

• Associate

Employment type

• Contract

Job function

• Biotechnology Research and Engineering Services