Kite Pharma
Biopharmaceutical
StatisticalProgrammerII
“Statistical Programmer II at Kite Pharma. Skills: Statistical programming, SAS, R. Efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries. Meet project deliverables and timelines for statistical data analysis and reporting”
What You'll Achieve.
Support of Gilead’s regulatory, scientific and business objectives
Industry & Context.
Problem solving skills; Analytical skills
What They're Looking For.
Must Have
Master's and 2 years of relevant experience OR Bachelor's and 4 years of relevant experience
Nice to Have
Degree in Biostatistics/Computer Science or equivalent, 5+ years of pharmaceutical/CRO experience, Prior experience in oncology, hematology, cell therapy strongly preferred, Knowledge of long term follow up trial knowledge strongly preferred, Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.), In-depth understanding of clinical programming and/or statistical programming processes and standards, In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH), Extensive experience with statistical programming using the SAS and R software including development and use of SAS Macros, R Packages, Experience with development of CDISC standardized ADaM datasets and specifications, Advanced knowledge in SDTM domains, Proven experience in leading programming activities, Excellent interpersonal, communication, problem solving, and analytical skills, Willing to handle multiple projects and ad-hoc tasks
What You'll Do.
Efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries, Meet project deliverables and timelines for statistical data analysis and reporting, Assess the quality and consistency of analysis data, Perform cross-study analyses, Automate study deliverables using internal macros or writing SAS macros, Assist in submissions of electronic data (e.
, SAS® data sets) to regulatory agencies, Provide programming support for study deliverables, Generate the production of statistical analysis datasets and outputs (e.
, tables, figures, and listings) for study reports and integrated summaries.
How You'll Work.
Team & Collaboration
Works collaboratively with internal colleagues and external vendors; Works collaboratively with Clinical Development staff; Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies; Participate in Programming and Clinical Data Science meetings
Communication Scope
Excellent verbal and written communication skills; Excellent interpersonal skills; Excellent communication skills
Process & Methodology
Leading programming activities
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