Job Description
Responsibilities: - The statistical programming contractor independently manages completed projects that involve global tasks, or cross functional teams.
- The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G.
- In addition, providing programming support for publication for our marketed drugs.
- Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) complying 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.
- 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.
- Job-Specific Competencies: Tackles difficult problems; identifies solutions and recommends action management.
- Influences communication toward common understanding and actionable results.
- 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.
Requirements: - Bachelor's Degree/master's degree in science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Bachelors + 7 year, 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.
- Pinnacle 21, XML and MS Office) Demonstrated ability to work independently and in a team environment.
- Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project.
- ISS/Client), 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.
- Core essential skill sets candidates must have to be considered for the role: Expert level of programming skills and problem resolution in SAS.
- Advanced knowledge of government regulations (such as CDISC and ICH guidelines) pertaining to drug development in multiple therapeutic areas.
- Solid Statistical Knowledge.
- Good oral and written communication skills.
Job Tags
For contractors, Work experience placement,