1. Develop and review SDTM and ADaM dataset specifications and other related documentation based on industry standards, sponsor’s specific requirements, and regulatory requirements. 2. Program and validate SDTM and ADaM datasets following approved dataset specifications. 3. Develop SAS programming codes to generate and validate statistical output reports of trial data based on the statistical analysis plan and statistical tables/listings/figures mock-up. 4. Develop and test SAS programming codes for clinical trial database logical checks and reports for ongoing data review. 5. Document data and programming information in accordance with corporate SOPs and guidelines. 6. Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines. 7. Develop and provide expertise in other programming and system administration areas when required. 8. Participate in developing and maintaining clinical trial data and statistical reporting standards to ensure that the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements. 9. May lead programming efforts for assigned client clusters when required. 10. Provide technical guidance and support to less experienced Statistical Programmers in the study team.
月薪70,000元以上
(固定或變動薪資因個人資歷或績效而異)A Master’s in Computer Science or Math/Statistics with at least seven years experience, or a Bachelor’s degree in Computer Science or Math/Statistics with at least ten years experience, or Associate degree with a minimum of twelve years experience, in clinical trial statistical programming and with demonstrated strong capability and sustained high level of performance as a Senior Statistical Programmer I.
1. 年終獎金 2. 優於勞基法年假制度 3. 年度健康檢查 4. 公司聚餐 5. 不定期舉辦公司活動 6. 完善的教育訓練