Statistical Programmer | Remote
Summary
Remote statistical programmer supporting clinical research studies: developing and validating SDTM/ADaM datasets, programming tables, listings, and figures (TLFs) for clinical trials, and producing regulatory deliverables using SAS, CDISC standards, Define-XML, and Pinnacle 21.
Salary: ₱80,000 – ₱110,000 per month
📢 𝗪𝗘’𝗥𝗘 𝗛𝗜𝗥𝗜𝗡𝗚: 𝗦𝗧𝗔𝗧𝗜𝗦𝗧𝗜𝗖𝗔𝗟 𝗣𝗥𝗢𝗚𝗥𝗔𝗠𝗠𝗘𝗥 | 𝗥𝗘𝗠𝗢𝗧𝗘
We are looking for a skilled Statistical Programmer to support clinical research studies through statistical programming, clinical data validation, and the development of high-quality statistical deliverables.
🔑 𝗞𝗘𝗬 𝗥𝗘𝗦𝗣𝗢𝗡𝗦𝗜𝗕𝗜𝗟𝗜𝗧𝗜𝗘𝗦:
• Develop, maintain, and validate SDTM and ADaM datasets for clinical trials.
• Program Tables, Listings, and Figures (TLFs) for interim analyses, data monitoring, and clinical study reports.
• Develop and validate annotated Case Report Forms (aCRFs).
• Perform data cleaning activities and resolve statistical data issues in collaboration with Data Management and Biostatistics teams.
• Develop and maintain dataset specifications, Define-XML, and Reviewer’s Guides.
• Validate SDTM and ADaM datasets using Pinnacle 21.
• Utilize SAS macros and programming standards to improve efficiency and quality.
🎯 𝗞𝗘𝗬 𝗤𝗨𝗔𝗟𝗜𝗙𝗜𝗖𝗔𝗧𝗜𝗢𝗡𝗦:
• Bachelor's degree in Statistics, Computer Science, or a related field.
• At least 1 year of clinical research experience, including 1 year of Statistical Programming experience in the biotechnology, pharmaceutical, or CRO industry.
• Strong working knowledge of SAS.
• Good knowledge of CDISC standards (SDTM and ADaM).
• Exposure to clinical trial data, Statistical Analysis Plans (SAP), TLF Shells, and programming specifications.
• Knowledge of Pinnacle 21 and XML programming is an advantage.
• Familiarity with ICH guidelines, GCP, and FDA/Health Canada regulatory requirements.
• Excellent analytical, organizational, and problem-solving skills.