Clinical Application Specialist IIISpectraforce Technologies • Raleigh, NC, US
Clinical Application Specialist III
Spectraforce Technologies • Raleigh, NC, US
job_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionIn 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. 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.
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
Qualifications
J-18808-Ljbffr
serp_jobs.job_alerts.create_a_job
Application Specialist • Raleigh, NC, US
Job_description.internal_linking.related_jobs
A company is looking for a Senior Clinical Documentation Specialist (RN required) (CCDS or CDIP cert preferred) - REMOTE.
Key Responsibilities Performs assessment of patient records to evaluate do...serp_jobs.internal_linking.show_more
Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.
This position qualifies for our UNC Rex...serp_jobs.internal_linking.show_more Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.
This positon trains and audits Inpatien...serp_jobs.internal_linking.show_more 
Providing clinical expertise, training, and support for medical devices, procedures, or therapies, potentially engaging in sales and client relations.
Key responsibilities include educating staff an...serp_jobs.internal_linking.show_more A company is looking for a Clinical Documentation Specialist I to support value-based care and ensure accurate documentation of clinical conditions and procedures.
Key Responsibilities Determine p...serp_jobs.internal_linking.show_more A company is looking for a Clinical Documentation Specialist, REMOTE.Key Responsibilities Ensure the accuracy and completeness of clinical documentation through extensive record reviews and inter...serp_jobs.internal_linking.show_more 
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into ...serp_jobs.internal_linking.show_more
The company was founded in 2016 to address the profound need for improved kidney stone treatment.Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resourc...serp_jobs.internal_linking.show_more A company is looking for a Clinical Specialist to join their remote team.Key Responsibilities Utilize motivational interviewing techniques to engage patients in services Complete necessary docum...serp_jobs.internal_linking.show_more 
This position is to provide solution-oriented consultative training, technical support and troubleshooting at customer sites, and remotely, on bioMerieux's diagnostic product lines.Effectively work...serp_jobs.internal_linking.show_more
Epic Clinical Documentation (ClinDoc) module.This role ensures that clinical workflows are streamlined, compliant, and effectively support providers, nurses, and other healthcare staff.The analyst ...serp_jobs.internal_linking.show_more
Care Access is working to make the future of health better for all.With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health ser...serp_jobs.internal_linking.show_more A company is looking for an Inpatient Clinical Documentation Associate Systems Analyst.Key Responsibilities Assist in system maintenance, troubleshooting, and optimization efforts Collaborate wi...serp_jobs.internal_linking.show_more Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into ...serp_jobs.internal_linking.show_more 
Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.
This positon trains and audits Inpatien...serp_jobs.internal_linking.show_more This position is to provide solution-oriented consultative training, technical support and troubleshooting at customer sites, and remotely, on bioMerieux's diagnostic product lines.Effectively work...serp_jobs.internal_linking.show_more A company is looking for an IT Epic Analyst II.Key Responsibilities Design, implement, maintain, and support assigned Epic software applications Plan implementation and upgrades of clinical syst...serp_jobs.internal_linking.show_more 
Epic Clinical Documentation Analyst (Hybrid).The Clinical Documentation (Clin Doc) Analyst supports the client Operated Healthcare Facilities in the ongoing support of the Epic Electronic Health Re...serp_jobs.internal_linking.show_more
Tennessee Licensed Clinical Documentation Specialist
VirtualVocations • Raleigh, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
RN Clinical Nurse III - 4 West : Intermediate Care
UNC Health Care • Raleigh, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Clinical Documentation Specialist Auditor- HIM Coding & CDI Quality
UNC Health Care • Chapel Hill, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Clinical Specialist
PrismHR • Cary, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Clinical Documentation Specialist
VirtualVocations • Raleigh, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Georgia Licensed Clinical Documentation Specialist
VirtualVocations • Raleigh, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Sr Clinical Trial Manager
Syneos Health / inVentiv Health Commercial LLC • Morrisville, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Raleigh, NC based Clinical Specialist - Remote, USA
Calyxo • Raleigh, NC, US
serp_jobs.filters.remote
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Florida Licensed Clinical Specialist
VirtualVocations • Raleigh, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
Field Application Specialist I - Michigan & Chicago area
bioMerieux Inc. • Durham, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Epic ClinDoc Analyst
ClinDCast LLC • Cary, NC, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Clinical Research Coordinator II
Care Access • Raleigh, NC, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Clinical Documentation Systems Analyst
VirtualVocations • Raleigh, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
CTM I / II
Syneos Health / inVentiv Health Commercial LLC • Morrisville, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Clinical Documentation Specialist Auditor- HIM Coding & CDI Quality
UNC Health • CHAPEL HILL, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Field Application Specialist I - Kansas / Missouri
bioMerieux Inc. • Durham, NC, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Ohio Licensed Epic Analyst II
VirtualVocations • Raleigh, North Carolina, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
Epic Clinical Documentation Analyst (Hybrid)
Serigor Inc. • Raleigh, NC, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted