
Manager, Statistical Programming
美国–远程临床开发与临床操作正式员工职位描述
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