Anjala Beegum A H

Highly organized and quality-oriented clinical SAS Programmer with 7 years of experience in developing and managing PMDA and FDA submissions. Demonstrated expertise in development and validation of specification, acrf, define.xml, reviewer's guide and ARM. Proficient in using SAS, SAS/MACROS, and SAS/SQL for developing and validating SDTM, ADaM, safety tables and listings outputs. Adept at customer communication and conducting training, with a proven ability to lead department-level initiatives and mentor team members.

• Developed and validated specifications, SDTM and ADaM datasets, along with safety tables and listings for 25+ studies submitted to PMDA and FDA.
• Proficient in creating and reviewing CRT package deliverables - acrf, SDRG, ADRG, define.xml, ARM including the m5 structure.
• In-depth expertise in PMDA legacy study submissions.
• Worked extensively on SDTM development of medical devices studies.
• Performed output validation through independent programming, pinnacle 21 validator and code review.
• Managed project team of 4-6 members, prioritizing and delegating tasks effectively to ensure productivity and quality.
• Facilitated customer interactions through calls and emails with Japan and Europe clients, ensuring clear and effective communication.
• Provided programming and review support for additional projects beyond assigned deliverables.
• Trained approximately 150 department members on various topics, improving overall team competency and knowledge.
• Mentored new joiners and fellow members in technical and project management aspects.
• Contributed to various department level initiatives while simultaneously working in projects:
• Prepared content for the CDISC Japan Interchange on BIMO.
• Actively participated as a member of the CJUG support team.
• Audited internal team projects and enhanced the department process as a major contributor of process initiative group.
• Audited internal team projects and enhanced the department process as a major contributor of process initiative group.
• Authored work instruction for acrf development.
• Reviewed the quality assurance checklist created for SDRG.
• Coordinated two week training program for Japan on-site project co-ordinator.