Description
Responsibilities- Generates or oversees the production of statistical output (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 statistical programmers.
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
- Designs and/or codes analysis files.
- Is responsible for all statistical 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.
- Must be capable of attending study team meetings as the primary statistical programming contact.
- Can create buy-in and support and has the ability to negotiate timelines.
Qualification
4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
2 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.