Spectraforce Technologies
Clinical Application Specialist III
Spectraforce Technologies, Raleigh, North Carolina, United States, 27601
Job Title
Clinical Application Specialist III
Location Remote
Duration 2 years - based on performance and business needs
Key Skills
SAS Programming
SDTM and ADaM programming and developing specifications
Supported/Led IB, DSUR, PSUR, ISS, ISE, Study CSR work
Solid understanding and experience with CDISC data standards
Good communication skills and team player
Purpose 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.
Responsibilities
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 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 process improvements are implemented.
Provide accurate and timely responses to requests from clients with a sense of urgency.
Be compliant with training requirements.
Qualifications
BS or MS in Statistics, Computer Science or a related field with at least 8 years of 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, macro and utilities development.
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Location Remote
Duration 2 years - based on performance and business needs
Key Skills
SAS Programming
SDTM and ADaM programming and developing specifications
Supported/Led IB, DSUR, PSUR, ISS, ISE, Study CSR work
Solid understanding and experience with CDISC data standards
Good communication skills and team player
Purpose 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.
Responsibilities
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 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 process improvements are implemented.
Provide accurate and timely responses to requests from clients with a sense of urgency.
Be compliant with training requirements.
Qualifications
BS or MS in Statistics, Computer Science or a related field with at least 8 years of 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, macro and utilities development.
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