Position Details:

Industry: Pharmaceutical

Duration: 12 months (++Possibilities of Extension)

Job Mode: Remote

• Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.
• In-depth knowledge on CDISC Standards, SAS programming concepts and techniques appropriate to the pharmaceutical industry.
• Experience in leading compound level data integration efforts to create pooled ADAM datasets by pooling data from multiple studies, completed and ongoing, across indications.
• Experience in ADaM specs and SAS programs development supporting ISS/ISE ADaM programming and submissions.
• Oversee and responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and ISE following Client’s SOPs, department, and project standards.
• Experience in supporting IB, DSUR and Annual Safety Reporting deliverables
• Ability to quickly learn internal macros, processes, and programming environment.
• •Team player with excellent communication skills and experience working with stat programmers, statisticians, data management personnel and Pharmacovigilance stakeholders.
• Oversee and responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan.
• Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data), as applicable.
• Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
• Ensure all Client’s process improvements are implemented.
• Provide accurate and timely responses to requests from clients with a sense of urgency.
• Be compliant with training requirements.

• BS or MS in Computer Science, Statistics, or a related field with SAS programming experience in Pharmaceutical or related industry.
• Extensive experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Excellent working experience/skill in SDTM and ADaM datasets creation/validation.
• High degree of technical competence and excellent communication skills, both oral and written.
• Demonstrated competency and hands-on experience in SAS programming on LINUX, LINUX shell scripting, , macro and utilities development.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)