Statistical Programmer

Company: Unicon Pharma
Location: Wayne
Posted on: April 6, 2021

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