Clinical Application Specialist II
Spectraforce
US
Remote
5 hours ago
Job Description
Job Title - Clinical Application Specialist II
Job Duration – 1 year
Job Location – Remote
Travel required - 5%
What are the top 3-5 skills, experience or education required for this position:
(1) in-depth understanding of SAS programming concepts and techniques related to drug/device development.
(2) in-depth understanding of CDISC Standards (SDTM and ADaM)
(3) experience in harmonizing clinical study data from multiple studies with divers study designs, data standards spanning multiple indications.
(4) experience in leading studies with hands-on experience for developing ADaM specs, ADaM programs and TLFs.
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.
• 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 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.
Interview rounds
2 rounds of screening and group interviews
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.
Job Duration – 1 year
Job Location – Remote
Travel required - 5%
What are the top 3-5 skills, experience or education required for this position:
(1) in-depth understanding of SAS programming concepts and techniques related to drug/device development.
(2) in-depth understanding of CDISC Standards (SDTM and ADaM)
(3) experience in harmonizing clinical study data from multiple studies with divers study designs, data standards spanning multiple indications.
(4) experience in leading studies with hands-on experience for developing ADaM specs, ADaM programs and TLFs.
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.
• 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 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.
Interview rounds
2 rounds of screening and group interviews
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.