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Graduate Intern, Statistical Programming of Biometrics

United States – RemoteClinical Development & Clinical OperationsIntern
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Job Description

We are seeking highly motivated and passionate individuals to join our Summer Internship Program! As an intern at Kite, you’ll have the unique opportunity to learn about cell therapy from some of the brightest minds in biotech while making a meaningful impact. We’re committed to developing early talent, and we welcome motivated individuals with a passion for transforming the way cancer is treated. The program also offers the opportunity for networking within Kite and Gilead, social events with fellow interns and Kite leadership as well as career development trainings while providing competitive compensation and relocation assistance for eligible candidates.

The Role:

The individual in this intern position will support the clinical research development process in the field of clinical trial programming using SAS or R. The intern will learn and apply CDISC standards for clinical trial within the standard Kite Pharmaceuticals setting as documented through company SOPs, guidelines and working instructions. You will support on transforming specifications in the Statistical Analyses Plan (SAP) into fully documented, validated programs by producing analysis datasets (ADaM) and summary tables, figures, and listings (TFL) required for the Clinical Study Report (CSR). Gain specific knowledge about the clinical data collected for the study.

Responsibilities:

  • Utilize Kite SOPs and guidelines, the trial protocol, annotated case report forms, Statistical Analyses Plan, and clinical database in preparation for producing analysis datasets (ADaM) and programming of the safety tables, figures, and listings (TFL) required for the Clinical Study Report (CSR). Gains specific knowledge about the clinical data collected for the trial.

  • Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy, and completeness of the data in preparation for clinical reporting.

  • Review the programming specifications, Statistical Analyses Plan (SAP), and table shells for completeness, correctness, and adherence to sited department guidelines and SOPs. Ensure all programming issues are resolved and updated in the SAP. Ensure additional specifications once programming commences are properly documented. Maintain programming team documents.

  • Transform specifications in the Statistical Analyses Plan (SAP) into fully documented, validated programs required for the Clinical Study Report. This includes required standard displays, safety displays of moderate complexity unable to use a standard macro that are well specified by the clinical study team, and efficacy related tables, figures, and listings.

  • Identify assignment priorities, timeline goals, and communicate priority-related issues and timelines to the programming team.

  • Ensure the efficiency, quality, and integrity of data reporting, and project activities implemented.

  • Demonstrated ability to carry out assignment, work efficiently, produce quality results with limited supervision.

Basic Qualifications:

  • 18 years or older

  • Minimum GPA of 2.8

  • Eligible to work in the United States without work authorization sponsorship now or in the future

  • Enrolled in a full-time graduate degree program at an accredited U.S. based university/college

  • Completed at least one year of study at an accredited university/college prior to internship commencing

  • Enrolled full-time in the Fall Semester at an accredited U.S. based university/college after the completion of the internship – with earliest graduation date of December 2024 or Spring/Summer 2025

  • Complete a 10-12 consecutive week internship between May and August

  • Able to relocate if necessary and work at the designated site for the duration of the internship

  • Not be employed at the time the internship starts

Preferred Qualifications:

  • Currently enrolled in Graduate Degree with emphasis in fields related to Bio/Statistics, Computer Science (software programming language focused), or Data Science with exposure to clinical research and statistical programming in SAS or R

  • Demonstrated proficiency in conducting statistical analyses using SAS or R

  • Knowledge in database set-up, data processing, elementary statistics and basic medicine terminology

  • Proficiency with MS Office Suite

  • Ability to identify issues and seek solutions

  • Ability to work both independently and collaboratively in cross functional teams in fast paced, dynamic team setting

  • Efficient, organized, and able to handle short timelines

  • Experience and/or interest in the Biotechnology, Pharmaceutical or health-care industry

  • Knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory policies