Senior Data Scientist

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Data Scientist role is a pivotal position within our pharmaceutical organization, responsible for ensuring compliance with FDA guidance while driving the adoption of state-of-the-art technologies. This role involves adhering to and implementing statistical methodologies to support various projects, including product development, quality control, and production processes. The Data Scientist will collaborate closely with cross‑functional teams to provide data‑driven insights and solutions, leveraging advanced analytical tools and technologies.

Additionally, the role includes responsibilities in data architecture, focusing on ELT processes and broader data management strategies to enhance data integration and management across the organization, while ensuring validated data requirements are met.

• Statistical Analysis:
  Design and conduct statistical analyses for production processes, product development, and quality control, ensuring compliance with FDA guidelines.
• Data Architecture:
  Develop and maintain data models, data flows, and data integration processes to support data‑driven decision‑making.
• AI and Advanced Analytics:
  Drive the adoption of AI and advanced analytics techniques to improve data analysis and insights.
• Acceptance Sampling Plans and OC Curves:
  Develop and implement acceptance sampling plans and Operating Characteristic (OC) curves to ensure product quality and compliance with regulatory standards.
• Collaboration:
  
  Work closely with cross‑functional teams, including R&D, quality assurance, production operations, and IT, to understand data requirements and deliver innovative solutions.
• Data Governance:
  Establish and enforce data governance policies and procedures to ensure data quality, consistency, and security.
• Training and Support:
  Provide training and support to team members on statistical principles, data architecture, and the use of analytical tools.
• Develop and maintain KPIs and other metrics, including the use of production process control charts, to identify, analyze, and interpret trends or patterns in complex data sets. This includes applying techniques such as Control Charts, Ppk, Cpk, Nelson Rules, and Normality assessments.

• Bachelor's in Statistics, Biostatistics, Data Science, or a related field with minimum of 6 years of experience in data analysis.
• Master's degree in Statistics, Biostatistics, Data Science, or a related field with minimum of 3 years of experience in data analysis.
• Strong statistical skills with the ability to identify, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• Preferred:
  Experience with Acceptance Sampling Plans, OC Curves, Confidence Intervals and Equivalence Testing.
• Preferred:
  Proven experience with FDA guidelines and regulatory requirements for cGMP and FDA CFR 211/820.
• Experience with data architecture, including SQL, ELT processes.
• Preferred:
  Proficiency in statistical tools such as R, Minitab, and Power
  
  BI.
• Knowledge of AI and advanced analytics techniques.
• Familiarity with data governance and data quality frameworks.
• Preferred:
  Version Control (Git).
• Preferred:
  Dashboard Visualizations (Power Bi, Shiny, Tableau).

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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