Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Data Specialist to join our Biostatistics team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- Create Data Submission Package including define.xml documents and related submission documents for SDTM and ADaM datasets for all regulatory submission;
- Conformance of Data Submission documents compliant to all specifications and guidelines outlined by the Clinical Data Interchange Standards Consortium (CDISC) and specific electronic data submission guidelines; and
- Provide support and assistance to Data Standard Analysts, Statistical Analysts, Biostatistician, and others as needed regarding data submissions.
Qualifications
- Bachelors degree in Math, Statistics, Computer Science, Life Science, or related area
- Experience with Microsoft Excel and Word
- Experience with Adobe
- Attention to detail and time management skills