Rajendra Singh

Working remotely as a Statistical Consultant to support pharmaceutical & biotech clients in USA (mostly CROs: ISHA Therapeutics, Amgen (via The Lotus Group), Symbiance, Symbiotech, Edetek) on clinical trials projects in the multiple therapeutic areas in phases 1-4 including working on Real-world evidence (RWE) (for the ad-hoc work or short-term contracts). Provided statistical inputs on clinical trial design, sample size, statistical analysis plan, protocol, clinical data and clinical study reports in multiple therapeutic areas in various phases of the clinical trials.

Worked remotely as an Associate Director Biostatistics to support Statistics component of the clinical trials projects on multiple therapeutic areas: Primary immunodeficiency disease (PID), Factor Xa inhibitor, and Protein C deficiency (Ceprotin) (vendor: PhaStar). Involved in clinical submission of Cuvitru and HyQvia products, and responded to FDA/PMDA queries.

Provided statistical inputs on clinical trial design, sample size, statistical analysis plan, protocol review, data review and clinical study reports in multiple therapeutic areas in some phases of the trials.

Worked on multiple pharmaceuticals and biotech clients to provide statistical inputs on clinical trial design, sample size, statistical analysis plan, protocol review, data review and clinical study reports in multiple therapeutic areas.

Provided statistical inputs on clinical trial design, sample size, statistical analysis plan, protocol review, data review and clinical study reports in multiple therapeutic areas.

Worked remotely as a Senior Biostatistician on multiple projects (Oncology for MM, AML and NSCLC-Phase 1-2) with Biogen Idec. • Worked on multiple phases of clinical trials including Real-world evidence (RWE) from Multiple Myeloma registry. • Review of statistical sections of the clinical study protocols. • Wrote Statistical analysis plan and mock-shell TFL for clinical studies. • Involved in review of CSR tables, listings and figures using SAS programming. • Discussed study milestone timeline and statistical deliverables during team meeting.

Worked with multiple pharma/biotech clients such as BMS, GSK, Novartis, etc., to provide statistical inputs on clinical trial design, sample size, statistical analysis plan, protocol review, data review and clinical study reports in multiple therapeutic areas in all phases of the trials.