Statistical Programmer Analyst III
1 DNA Way South San Francisco, California 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
Duties: Sr. Clinical Programmer
- The Sr. Clinical Programmer (CP) develops and maintains clinical study databases as a member of Clinical Data Management (CDM).
- Working in collaboration with Data Managers and functional service providers, they are responsible for providing quality study databases and ensuring that technical database designs and edit checks are representative of protocol specifications.
- The Sr. Clinical Programmer also implements database changes due to protocol amendments.
- Lead Clinical Study Database design, development, and maintenance in Medidata Rave, in collaboration with the Study data management teams and internal/external partners
- Provide senior level technical and functional expertise as part of the Clinical Project Teams Drive the development of the Case Report Forms and edit checks according to protocol specifications, following CDASH/CDISC standards and complying with data collection standards
- Serve as the subject matter expert on data collection strategy and EDC system functionality
- Serve as Lead programmer in managing the day-to-day activities on multiple projects for study start-up and database amendments
- Develop, maintain and enhance working relationships and networks within and outside of CDM at study, program and project level
Skills: Core Competencies:
- Solid hands-on experience and skills in Medidata RAVE for setup and maintenance of Clinical Study Databases
- Excellent organizational, written and communication skills
- Ability to collaborate with multiple teams, external partners and key stakeholders
- Hands-on experience with Custom function development in Rave using C#
- Experience with SAS data listings, data visualization techniques, and custom report development
- Ability to manage multiple tasks/projects and time pressure
- Hands-on experience with Spotfire application desired
- BA/BS degree with 5-8 years related experience of which 4 years is in clinical data management of which 2 years includes direct experience with Electronic Data Capture (EDC) design and deployment
- MS degree in biological sciences, statistics, computer science or a related field, and at least 4-6 years related experience, of which 3 years is in clinical data management and 2 years direct experience with Electronic Data Capture (EDC) design and deployment
- Experience with and knowledge of the clinical trial data management process is required.
- Advanced-level experience with Medidata RAVE is required
- Understanding of Pharma Development principles
- Understanding of Clinical Trial protocols, Case Report Forms (CRF) and the core elements of the Clinical Study Database Life Cycle - from planning, to set up, conduct and closeout
- Knowledge of device or pharmaceutical industry regulatory requirements
- Knowledge of pharmaceutical industry trends including the usage of CDISC standards