Statistical Programmer
Company: Unicon Pharma
Location: Wayne
Posted on: April 6, 2021
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Job Description:
Location: Morris Plains, NJ 07950 Duration: 07 Months-Contract.
Job Description: 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 specifications.
Create/validate CDISC compliant SDTM and ADaM datasets by following
data specification. 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 shells. Prepare data
submission packages including define.xml and data reviewers' guide.
Collaborate with data manager(s) to ensure data quality meeting
high standard. 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 needed. 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). Education/ Experience:
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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