Job Description
Job Responsibilities:
- Primarily works at the study, product / program level
- Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices.
- Manage and Delivers assignments with good quality and within timelines
- Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs.
- Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.
- Responsible for the standardization of GSD deliverables (datasets and associated TLGs) 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.
Skills:
- Expert level of programming skills and problem resolution in SAS.
- Strong knowledge of Adam (all aspects-related)
- Submission experience (required)
- Advanced knowledge of government regulations (such as CDISC and ICH guidelines) pertaining to drug development in multiple therapeutic areas.
- Tackles difficult problems; Identifies solutions and help leading decisions to resolve
- Manage and deliver assignments with quality and within timelines by being independent and proactive
- Solid Statistical Knowledge
- 07+ years of relevant Pharma experience recommended
Education/Experience:
- Education Required: Bachelor’s Degree/ Master’s degree in science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Experience Required: Bachelors + 7 years, Masters + 6 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
- Proficient knowledge of clinical trials and drug development process, industry standards, 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, TLGs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
- Demonstrated ability to work independently and in a team environment.
- Functional Knowledge: 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) Inspection deliverables).
- Have solid knowledge of statistical models used for efficacy data analysis.
- Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
Job Tags
Work experience placement