Job Title
Pay Range: $56.97hr - $61.97hr
Requirement/Must Have:
- Bachelor’s Degree/Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Bachelors + 5 years, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
- Proficient knowledge of clinical trials and the drug development process, industry standards, and statistical concepts used in analysis and submissions of clinical trial data.
- Strong understanding of SDTM, ADaM standards and Implementation guides.
- Demonstrated proficiency in using SAS to produce analysis datasets, TLFs, eSUB components and using other software applications (e.g. Pinnacle 21, XML and MS Office).
- Demonstrated ability to work independently and in a team environment.
Responsibilities:
- Primarily works at the Study, product/program level.
- Provides comprehensive programming support, including developing programs, ADaM specifications, and analyses (datasets, TLFs) that comply with regulatory requirements, departmental SOPs and work practices.
- Manages and delivers assignments with good quality and within timelines.
- Provides programming support to CDISC based e-submission.
- Develops, debugs, and enhances SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
- Implements programming standards and complies with regulatory requirements among project team members and across all projects.
- Communicates project status and resource gaps to management.
- Responsible for the standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area.
- Provides input on opportunities for process improvement.
- Proactively communicates issues impacting programming deliverables with Stat or DM team members.
Nice to Have:
- Specialized or Technical Knowledge Licenses, Certifications needed.
Skills:
- Expert level of programming skills and problem resolution in SAS.
- Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspections).
- Solid knowledge of statistical models used for efficacy data analysis.
- Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.