Clinical Application Specialist II
Clinical Application Specialist II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- This role is responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data sets for one or more compounds/indications or therapeutic areas.
- This role must effectively interface with team members from Statistics Data Sciences Pharmacovigilance and Patient Safety 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/Client ADaM programming and submissions.
- Oversee and responsible for the creation and validation of SDTM ADaM and TLFs for CSR ISS and Client following clients 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 clients 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.
- In-depth understanding of SAS programming concepts and techniques related to drug/device development.
- In-depth understanding of CDISC Standards (SDTM and ADaM)
- Experience in harmonizing clinical study data from multiple studies with divers study designs data standards spanning multiple indications.
- Experience in leading studies with hands-on experience for developing ADaM specs ADaM programs and TLFs.
Employment Type
Full-time
