drjobs Statistical Programmer

Statistical Programmer

Employer Active

1 Vacancy
drjobs

Job Alert

You will be updated with latest job alerts via email
Valid email field required
Send jobs
Send me jobs like this
drjobs

Job Alert

You will be updated with latest job alerts via email

Valid email field required
Send jobs
Job Location drjobs

Newark - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:
  • Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD .
  • Guarantee quality of statistical output produced by external provider to program tools to support data review activities and data visualization to collaborate on the interpretation and communication of trial results .
  • Contribute to regulatory submissions converting data according to regulatory requirements preparing integrated analyses and related documentation .
  • Perform post-hoc analysis for exploratory purposes or to support regulatory requests to prepare analysis for paper publications .
  • Support the development of standard operating procedures .
  • To convert data to CDISC SDTM following project specifications .
  • Develop SAS programs to generate analysis datasets (CDISC compliant) .
  • Produce datasets documentation according to CDISC and FDA requirements () and/or to review analysis datasets documentation prepared by providers .
  • Develop SAS programs to produce tables listings and figures as planned in the statistical analysis plan and to support data review activity before database lock .
  • Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports .
  • Writing documenting and performing quality control review of SAS programs
  • Perform ad hoc analysis for various statisticians requirements .
  • Support statisticians in the preparation and/or review and QC of statistical package for FDA submissions .
  • Perform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with international requirements and with internal SOP/Standards.
Requirements:
  • Bachelors degree or higher preferably in a scientific discipline such as Statistics Mathematics Computer Science or a related applicable field .
  • Good experience in SAS .
  • Proficient in Macro Facility .
  • Extensively involved in clinical data analysis and preparation of SAS Data sets Reports Tables Listings Summaries and Graphs according to Standard Operating Procedures (SOPs) .
  • Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) Analysis Dataset Models (ADaM) Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification () .
  • General knowledge of statistical methods .
  • Have excellent analytical problem solving communication and interpersonal skills .
  • Effective verbal and written communication skills .
  • Strong commitment to quality .
  • Ability to work in a team-based environment.

Employment Type

Full-time

Company Industry

About Company

Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.