• Oversaw lean internal team augmented by contractors and outsourcing. Accountable for Biometrics functions, encompassing Biostatistics, Statistical Programming, and Data Management in Research, Clinical Development, and Medical Affairs. – Contributed to successful submissions of FDA Biologics Licensing Application (BLA) , sBLA, and EMA Marketing Authorisation Application (MAA) for the leading compound Elahere®. Both BLA and sBLA approved with priority review. Supported partners with regulatory submissions in other geographic areas. – Directed Biometrics activities to support approximately 10 clinical studies across 4 programs with varying solid tumor and hematologic indications. – Strategic partner and data expert to study and product teams providing key inputs to clinical study design, data analyses and interpretations, internal trial monitoring and conduct, and external communications.• Provided critical statistical inputs to senior management and cross-functional partners in strategic discussions on clinical development programs, publication strategies, and HTA reimbursement strategies.• Continued process improvement and standardization to increase efficiency and productivity while maintaining high quality standards.• Nurtured and developed team members by providing technical guidance for day-to-day work, responding to and proactively planning for career development to ensure continued growth and success.

• Provided critical statistical inputs to stakeholders and partners in discussions on clinical development programs.• Oversaw 15 team members on clinical study design, clinical trial data analyses and statistical outputs (table, listing, figure [TLF] outputs with associated data packages when applicable) for regulatory submissions, publications and conference presentations and posters, internal trial monitoring needs, and other business needs.• Developed SOPs for Biostatistics and Statistical Programming. Presented process during FDA and EMA inspections at headquarters.

• Instrumental in strategy discussions and oversaw 2 sNDA submissions and 1 EU Type II variation submission, leading to successful approvals.• Oversaw statistical activities for Multiple Myeloma (MM), Diffuse large B-cell lymphoma (DLBCL), and dedifferentiated liposarcoma (DDLS) development programs.

• Oversaw all statistical activities for Multiple Myeloma (MM) development program.• Lead Statistician for FDA New Drug Application (NDA) and EMA MAA submissions for the company’s leading compound XPOVIO®. Led statistical activities related to submissions, IR responses, preparations for FDA Oncologic Drugs Advisory Committee (ODAC) meeting, and EMA Scientific Advisory Groups (SAG) and Oral Explanation (OE) meetings. Both NDA and MAA led to successful approvals.

• Served as study statisticians for 2 neoGAA studies including a phase 3, pivotal trial and a phase 2 trial, and 1 Pompe long-term follow-up study. Led statistical efforts related to trial design, protocol/SAP development, and trial conduct and monitoring. Worked with programming team for planning and execution of trial deliverables• Provided methodology support to Sanofi Genzyme Biostatistics group on various studies