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Manager, Statistical Programming

United States – RemoteClinical Development & Clinical OperationsRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Does this sound exciting to you?

We are in search of a Manager, Statistical Programming to join our team!  Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient and high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific, and business objectives.

Responsibilities of the Manager, Statistical Programming include, but are not limited to:

  • Works collaboratively with Clinical Registry and Data Statistical Science teams to meet project deliverables and timelines for statistical data analysis and reporting; serves as project leader

  • Utilizes internal databases such as clinical trial data, electronic medical records, health claims, the patient reported outcomes, registries, and publicly available data to execute inhouse analytical projects

  • Generates the production of programming deliverables (e.g., tables, figures, listings) for clinical registry study and data science reports, as well as integrated summaries; interacts within Biometrics and Clinical Data Science, Clinical Development, and Regulatory Affairs groups on a frequent basis

  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures

  • Conducts analyses and develops programming specifications for descriptive and complex statistics in studies using registry or real-world data

  • Performs programming using SAS or R, testing, mapping, and documentation of registry and real-world evident projects to meet business needs

  • Responsible for all programming activities within a project or equivalent and implements strategic initiatives

  • Actively shares experiences and discusses possible process enhancements at programming meetings

  • Recommends potential trainings

  • Other duties as assigned

Basic Qualifications:

  • MS/MA degree in Biostatistics, Computer Science, or equivalent and 4+ years’ experience in pharma/biotech OR

  • BS/BA degree in Biostatistics, Computer Science, or equivalent and 6+ years’ experience in pharma/biotech OR

  • High School degree and 10+ years of experience in pharma/biotech

Preferred Qualifications:

  • Degree in Biostatistics or Computer Science

  • 6+ years of pharmaceutical/CRO experience

  • Knowledge of registry and real-world data; experience in observational research, programming execution, and communication strongly preferred

  • Extensive statistical programming experience using both SAS and R; demonstrated proficiency in statistical analysis programs strongly preferred

  • Prior experience in oncology, hematology, and cell therapy

  • In-depth understanding of clinical programming and/or statistical programming processes and standards

  • Advanced knowledge in CDISC standards (e.g. ADaM)

  • Proven experience in leading programming activities

  • Excellent interpersonal, communication, problem solving, and analytical skills

  • Ability to lead and manage multiple concurrent projects

  • Ability to resolve study related issues and conflicts within project

  • Ability to create buy-in and support and adept at negotiating timelines