Experience

The Gurus LLC

• Armenia
• Biotechnology Research
• 1 - 100 Employee

• Mid-level Statistical Programmer

  • Jun 2022 - Present

  • Produce SDTM /ADaM Data Sets based on Implementation Guide and Data Specifications.• Program analysis datasets, tables, listings and figures (validation) for Phase I to III clinical trials and submission activities.• Provide Quality Control for derived datasets and outputs to ensure the output is 100% match.• Develop and enhance SAS macros for statistical analysis output generation.• Communicate effectively within a multi-disciplinary project team to prioritize the assigned missions and complete assigned tasks on time.• Implement data management plans and approved SAP designed to meet project timelines. • Communicate timely status updates to other team members in the department. • Active contribution on process improvement with support of Lead Biostatistician / Designee.• Assisting Senior Programmers in mentoring Junior Team members. Show less

• Junior Statistical Programmer

  • Sep 2021 - Jun 2022

  • CRF annotation according CDISC standards.• Document data and programming information in accordance with SOPs and/or clinical trial sponsor's specific requirements.• Converting from Excel data records to SAS datasets, non-CDISC compliant datasets to CDISC compliant datasets.• Assist in developing SDTM data mapping specifications.• Program SDTM and ADaM datasets according to approved dataset specifications.• Generate complete and accurate statistical tables and listings in accordance with Statistical Analysis Plan (SAP) and well-defined formats.• Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor's specific requirements.• Understand and conduct work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and trainings, and international regulatory requirements. Show less