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.  

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