Gilbert Ruban V C
Clinical Biostatistician (For UBC) @ Orcimed Life Sciences| SAS | Statistics | CDISC | ADaM | SAP | Shell preparation | R- Program | EXCEL | Power BI | SPSS | SYSTAT | Graphpad prism | Phoneix WinNolin |
- Role
- Clinical Biostatistician at OrciMed Life Sciences Private Limited
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Gilbert Ruban V C
Currently working as a Clinical Bio-Statistician at OrciMed Life Sciences knowledgeable in SAS, STATISTICS, SPSS And SYSTAT. Also proficient in,1. Graphpad prism 2. Phoenix software3. Pinnacle Software 4. CDISC5. SDTM & ADaM6. Shell preparation 7. SAP preparation 8. R Language 9. Provantis 10. EXCELOpen to work as a Bio-Statistician/SAS programmer for clinical trials/BABE.contact email: g••••••••@gmail.comph: 97••••••63
Experience
Clinical Biostatistician
OrciMed Life Sciences Private Limited
Nov 2024 — Present · Hyderabad, IN
Collaborate with clinical research teams to design clinical trials and observational studies.2. Develop SAP including sample size calculation, randomisation schedules and data analysis methodologies.3. Provide input on study protocol to ensure sound statistical methods are integrated.4. Perform statistical analysis on clinical trial data to evaluate the efficacy and safety of medical treatments or intervention.5. Using statistical software ( SAS, R or SPSS) for data analysis, modelling and simulation.6. Interpret results and assist in making informed clinical decisions.7. Contribute to CSR, manuscripts and regulatory submission documents.8. Ensure accurate and clear presentation of statistical findings in tables, graphs and written formats.9. Prepare detailed documentation for regulatory submission ( FDA, EMA).10. Work closely with other biostatisticians,data managers and clinical researchers to ensure data integrity and statistical rigor.11. Ensure adherence to GCP, regulatory requirements and ICH E9 for statistical analysis in Clinical trials.12. Open CDISC validator for SDTM and ADaM datasets validation.13. Generating reports and validation in Pinnacle 21.14. Validating and Generating SOP, MOCK SHELL, SAP for the study.15. participating in project meetings and provide statistical expertise.16. Explaining complex statistical concepts to non- statistical stakeholders in an understandable manner.
Education
Loyola College
bsc, Statistics
2015 — 2018
Bharath Institute of Higher Education and Research
Msc, Statistics
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