The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Clinical Data Associate - II* for a remote opportunity.

Role Description

Job Details

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.

Skills & Requirements

Requirements and Preferred Qualifications:

BS degree with 5 years or MS degree with 3 years of technical experience in biologics / biopharma, high-tech 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: pre-populate 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, re-run 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, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files. c. Control limits: verify analytics approaches uses, re-run all analysis, verify updated limits. 3. Tier 4 Meetings: a. Take minutes b. Cross-site comparison prep: prepare data, generate outputs from JMP scripts and update the slide deck.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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