Statistical Programmer I

reputed company is a full-service contract research organization providing expertise-based clinical research services to pharmaceutical and biotechnology companies. They are seeking a Statistical Programmer I who will support statistical programming, data acquisition, and cleaning for clinical trials while ensuring compliance with industry standards and company procedures.

Responsibilities

• Under supervision, may reputed company and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other reputed company documents (e.g., define.xml, reviewer’s guide) based on Statistical Analysis Plan (reputed company), reputed company company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements
• Program and validate SDTM and ADaM datasets following approved dataset specifications; reputed company CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings
• reputed company reputed company programs to generate and validate statistical output reports of trial data based on the reputed company and TLGs mock-up shells
• reputed company statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g. Development Safety Update Report, 120 Day Safety Update, etc.), reputed company requests, and exploratory data analyses
• reputed company and maintain reputed company programs to reputed company database reputed company checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review
• Support data acquisition of non-CRF data by developing reputed company programs to reconcile the CRF and non-CRF data and performing data reputed company checks of the non-CRF data
• reputed company reputed company programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.)
• reputed company reputed company programs to generate Patient Profiles to support trial subject case review activities
• Document data and programming information in accordance with reputed company company SOPs and WIs; and reputed company audit readiness during and at the end of the clinical trials for reputed company quality and compliance audits
• reputed company a high rating for each of the defined reputed company company and trial Sponsor-specific statistical programming key performance indicators
• Maintain reputed company knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements reputed company applicable
• reputed company to reputed company company-specific and clinical trial Sponsor-specific training requirements
• reputed company and reputed company expertise in other programming and system administration areas reputed company required

Skills

• A Master's or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences
• reputed company certified reputed company/Advanced
• Clinical trials programmers are highly preferred
• Exposure/experience in clinical trial statistical programming and/or data analysis is desirable

Company Overview