Manager, Statistical Programming
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POST DATE 9/18/2016
END DATE 11/9/2016
Foster City, CA
JOB DESCRIPTIONCurrently looking for qualified candidates at all levels to be part of an exciting team in the following therapeutic areas: HIV, Cardiovascular, Liver Disease, Oncology, and Respiratory/Inflammation. Levels and title can be determined after assessment.
Candidates will be expected to have familiarity/expertise in the production/validation of SDTM/ ADaM datasets and Tables, Listings, Figures as well as the ability to utilize global macros as appropriate for Phase 1-3 studies.
Essential Duties and Job Functions
Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
Generates or oversees the production of programming deliverables(e.g., tables, listings) for study reports and integrated summaries.
Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project.
Manages a small team of programmers.
Designs and/or codes analysis files.
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
Is responsible for all programming activities within a therapeutic project or equivalent.
Provides primary and secondary programming support as needed.
Implements strategic initiatives.
Excellent verbal and written communication skills and interpersonal skills are required.
Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions.
Must be able to interact with others to define and produce user-defined statistical reports (e.g., ad hoc requests).
Has the ability to resolve study related issues and conflicts within a therapeutic project.
Can create buy-in and support and has the ability to negotiate timelines.
Has the ability to directly supervise personnel.