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Job Location: Jersey City, NJ
Job Title: Safety SAS Programmer/Safety Data Manager
Hours Per Week: 35 hours/week
Location: NJ (Hybrid, will need to be onsite 1-2 times a week)
Contract Length: 12 months
POSITION OVERVIEW/SUMMARY
The Safety Data Manager manages Drug Safety Data Systems to ensure the timely creation, deployment and maintenance of databases required by Drug Safety projects. The incumbent analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and designs and programs reports based on the data reporting requirement in accordance with SOPs, client requirements, and regulatory guidelines.
The Safety Data Manager will be responsible for development of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring as well as post-marketing reporting requirements. The incumbent works closes with other functional groups such as medical safety evaluation team, pharmacovigilance operation, case processing, quality and compliance team to collect the requirement and improve the deliverables. The Safety Data Manager ensures all the activities are quality controlled and validated. The role also resolves Drug Safety data integrity issues and addresses database design inconsistencies over time by improving standardized approach. Incumbent will also participate in the drug safety system upgrade project and provide support to innovate digitalization of the PV operation by applying automation and AI technologies as business expands and as regulations require.
KEY RESPONSIBILITIES
- Performs Clinical Safety Data handling with SAS programming and analytical tasks:
- Create SDTM datasets for the clinical safety data using SAS based on the specifications and SDTM Implementation Guide as per requirement and standards of the company.
- Understand and utilize SDTM specification and Annotated eCRF according to SDTM variables to apply study specific variations in addition to the general standardization.
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- Extensive working knowledge on CDISC/SDTM standards.
- Create various SDTM datasets and ADAM datasets as per Specifications for on-going studies for safety signal detection.
- Work with Clinical Trials data such as Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), ECG, Vital Signs and other data domain as requested.
- Generate tables, listings and graphs with SAS Basic and SAS Macro.
- Develop and Validate SAS programs to produce analysis datasets and reports including routine and ad-hoc requests.
- Independently analyze and investigate data issues and solve technically complex problems.
- Deliver accurate, high-quality, and on-time of clinical programming deliverables.
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- Performs post-market Safety Data handling with IBM Cognos and SAS programming and analytical tasks:
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- Create Drug Safety reports using safety reporting tool (IBM Cognos) which is a data mart of the Safety database (Argus).
- Deliver and enhance compliance monitoring metrics for the PV activities.
- Provide aggregate reports data output using the reporting tool.
- Provide signal detection report from internal (Argus) and external (FAERS) safety databases.
- Participate in validation of the reports for quality and inspection readiness.
- Performs special tasks:
- Maintain MedDRA dictionary to deliver output with the latest MedDRA version.
- Develop and maintain systematic criteria and algorithm of selecting adverse event terms for the labelled or expected event and safety signal/risk and make them up to date along with the MedDRA version.
- Maintain and support SharePoint Signal Tracker system. Utilize Power Automate feature to apply workflow to support signal management process.
- Participate in Argus version up project.
- Evaluate automation and AI technologies to enhance PV activities and operation.
- Performs Project Management tasks:
- Meet with clients to take user requirements and clarify specific requirements of each project.
- Delegate project tasks based on junior staff members’ individual strengths, skill sets and experience levels.
- Track project performance, specifically to analyze the successful completion of short- and long-term goals.
- Develop comprehensive project plans to be shared with clients as well as other staff members.
- Use and continually develop leadership skills.
- Communicate project status and key project issues to subject matter experts.
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RELATIONSHIPS
Reporting:
- Reports directly to Associate Director, Drug Safety Data.
Managerial:
- Individual contributor.
Other:
- Works autonomously and cross-functionally with domestic and international colleagues in Drug Safety, Clinical Research, Data Science, Regulatory and Quality Assurance as needed to implement assessment and surveillance strategies.
- May also work with external key opinion leaders to obtain guidance on assessment and surveillance implementation and emerging methodology.
QUALIFICATIONS
Education:
- BA/BS in a life or computer science, Master’s Degree in Science, Biological or Computer Science preferred or a combination of education and experience.
Professional Experience:
- 5+ years pharmaceutical experience in clinical and/or safety setting for investigational or post-marketing product.
- Experience with clinical studies.
- Experience with regulatory submissions (e.g., NDA, MAA, DSUR, PBRER, PADER, etc.).
- Experience which demonstrated proficiency in SAS, SAS Enterprise Guide and SQL.
- Experience in visualization tool (e.g., SpotFire, MS-Power BI).
- Experience in reporting tool (e.g., IBM Cognos or BusinessObjects).
- Strong experience in using data management technologies, safety data system (e.g., Argus, Arisg), clinical data management systems, electronic data capture, data review tools, and data warehousing.
- Experience in developing drug safety data management standards (CDISC, SDTM, ADAM).
- Experience in the use of computer software systems (SharePoint, MS-Access, Word, Excel, PowerPoint, Microsoft Project, Visio, etc.).
- Programming and reports validation experience.
- Experience managing multiple projects – often complex in nature and with both internal and external stakeholders – under short timelines and within a cross-functional, project team environment.
Knowledge and Skills:
- Demonstrate knowledge in research design, system validation, E2B / CDISC, standard coding dictionaries (MedDRA).
- Ability to creatively use programming skills across variety of tasks in the Clinical Programming area.
- Critical thinking skills, ability to set priorities and develop strategies/studies to answer complex research questions.
- Excellent problem solving, analytical, organization and time management skills.
- Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans).
- Provide (and contribute to) consistent, high-quality written deliverables (e.g., drafts of study reports, presentations, publications, and other key project documents).
- Excellent oral communication and presentation skills, including experience with multicultural audiences.
- Demonstrate positive attitude, customer focus and flexibility.
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