Company: Unicon Pharma
Posted on: November 16, 2021
Location: Morris Plains, NJ 07950
Duration: 07 Months-Contract.
Responsible for providing programming support to clinical trial
data analysis, clinical study reports, publications, interim
analysis, ad hoc analysis, and submission data package. Interacting
with other functional members in a clinical study team and
representing statistical programming to provide all analytic
support and milestone programming deliverables.
Providing technical guidance or supervision to junior programmers
when necessary. Working closely with data managers within Clinical
Data Science to help ensure the accuracy and quality of the data in
the clinical trial database.
Essential Job Functions (Primary Responsibilities)
Develop/validate and review of SDTM and ADaM data
Create/validate CDISC compliant SDTM and ADaM datasets by following
Perform statistical analysis and generate analytic reports,
Tables/Listings/Figures, and Ad-Hoc outputs in support Clinical
Study report and exploratory analysis.
Works closely with other programmers to ensure the quality of all
deliverables and project timelines are met.
Work collaboratively with study biostatistician by reviewing and
providing inputs for study statistical analysis plan and TFL
Prepare data submission packages including define.xml and data
Collaborate with data manager(s) to ensure data quality meeting
Review eCRF and data edits specification to ensure all data
required by the protocol are collected and cross-checked to achieve
good quality data.
Participate in UAT test during the study database setup when
Provide statistical programming support to the clinical study team
for all assigned clinical project.
Supervising junior programmers, managing programming vendors, and
representing statistical programming group in project meetings.
Ensure that all departmental standard operating procedures that
govern any aspect of their work are adhered to.
Core Competencies (Knowledge, Skills, And Abilities)
Good knowledge of SAS Base, SAS Graph and SAS Macro.
Advanced programming skills in data manipulation, statistical
analysis, and reporting.
Proven knowledge of clinical trials, CDISC standards, regulatory
guidance, GCP, and ICH Guidelines.
Ability to manage multiple assignments in a timely fashion.
Good written and verbal communication skills.
work independently as well as team environment.
Must have good communication skill (verbal and written).
Bachelor's degree with 5+ years or Master's degree with 3+ years of
work experience in pharmaceutical/biotech or related industry.
Oncology or/and regulatory submission experience preferred.
Keywords: Unicon Pharma, Wayne , Statistical Programmer, IT / Software / Systems , Wayne, New Jersey
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