Clinical SAS Programmer

Edison, NJ, US • Posted 30+ days ago • Updated 1 hour ago

Full Time

On-site

Fitment

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Job Details

Skills

Budget
Quality Control
Publications
Regulatory Compliance
Documentation
XML
InfiniBand
Collaboration
Operational Excellence
SAP
Data Transformation Services
Defense Travel System
DTA
Data Management
Clinical Trials
Reporting
Regulatory Reporting
CDISC
Graphics Design
Analytical Skill
Communication
SDTM
SAS
Macros
NDA
Management

Summary

Responsibilities:

Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget.
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences.
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications.
Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.
Ensure timely delivery of all statistical deliverables for each study assigned.
Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items.
Follow departmental SOPs and processes for operational excellence.
Lead statistical programming activities for regulatory submissions following CDISC standards.
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan.
Take ownership for the completion of SDTM and ADAM specifications for assigned studies.

Requirements:

Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Strong SAS programming and graphic programming skills
ble to guide the successful completion of major programs and projects.
Strong analytical and communication skills
Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies.
Broad knowledge of medical/biological terminology in relevant therapeutic areas.
Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses.
Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus.
Experience in management of CROs with respect to statistical programming.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 1eee6ef190692201357d2b32e25004f4
Posted 30+ days ago

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Clinical SAS Programmer

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Job Details

Skills

Summary

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