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Statistical Programmer Consultant
Job Description
Our client is looking to add a Statistical Programmer Consultant to their team on a contract basis.
Responsibilities:
Responsibilities:
- Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs
- Creates and reviews annotated CRF to SDTM datasets
- Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives
- Functions as a positive role model for setting high expectations for quality, creativity and project ownership
- Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
- Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers)
- Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
- Involved with the strategy for process improvement
- Identifies new tools to increase efficiency and quality
- 8+ years of biotech or pharmaceutical industry experience as statistical programmer
- BS or MS degree in Statistics, Biostatistics or Computer Science or Engineering. MS preferred
- Strong experience in CDISC SDTM/ADaM programing
- Strong SAS experience building complex Table, Listing and Figures
- Direct experience with eCTD submissions(FDA/EMA/PMDA)
- Experience with creating Define.xml, reviewer’s guide
- Good communication skills, can work independently under supervision.