The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia. More than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence.
Clinical Programmer
Location
United States
Posted
3 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
Stefanini Group is hiring a Clinical Programmer for a 100% remote role. The position involves providing comprehensive programming support for clinical trials.
- Shift Schedule: Regular 40 week working schedule (morning)
- Duration: Up to 2 year assignment
The Clinical Programming (Contractor) is responsible for:
- Managing the timely and accurate execution of programming components of clinical trials.
- Independently managing completed projects that involve global tasks or cross-functional teams.
- Providing inputs to design of CRFs, Data Transfer specifications, creation of SDTM specifications and datasets, and reporting results of clinical trials.
Qualifications
- 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 drug development process, industry standards, database concepts used in clinical trials.
- Strong understanding of SDTM standards and Implementation guides.
- Demonstrated proficiency in using SAS to produce study SDTM datasets, 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.
Requirements
- Expert level of programming skills and problem resolution in SAS.
- Expert level of knowledge in CDISC based e-submission (creation of SDTM datasets and associated documents/specifications in study/project).
- Solid knowledge of Clinical data, SDTM IG, and Pinnacle 21.
- Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
Benefits
- Listed salary ranges may vary based on experience, qualifications, and local market.
- Some positions may include bonuses or other incentives.
Job Requirements
- 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 drug development process, industry standards, database concepts used in clinical trials.
- Strong understanding of SDTM standards and Implementation guides.
- Demonstrated proficiency in using SAS to produce study SDTM datasets, 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.
- Expert level of programming skills and problem resolution in SAS.
- Expert level of knowledge in CDISC based e-submission (creation of SDTM datasets and associated documents/specifications in study/project).
- Solid knowledge of Clinical data, SDTM IG, and Pinnacle 21.
- Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
Benefits
- Listed salary ranges may vary based on experience, qualifications, and local market.
- Some positions may include bonuses or other incentives.
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