Cleopatra DeLeon

• Expanded business opportunities by bringing CDISC ADaM/SDTM capability to Peri-/Post-Approval Services division.
• Oversaw study oversight, offering recommendations on resourcing, timelines, and study management.
• Evaluated new technologies and programming languages to stay at forefront of industry trends, optimizing company offerings accordingly.
• Developed robust applications by utilizing agile methodologies and industry best practices.
• Led and built analytical team, growing it from 2 to 9 full-time personnel. Delivered comprehensive training programs to junior developers, enhancing their skills in various coding languages and tools essential for project requirements.
• Managed diverse team of programmers, fostering professional growth and skill development in various programming languages.
• Enhanced team productivity by implementing efficient programming processes and tools.

• People Manager in PPD Center of Excellence - Data Transformation and Submissions Team.Lead and guide therapeutic area teams in transforming raw data sources into CDISC SDTM database structures, and preparing eCTD submission packages including annotated Case Report Forms (aCRF) eCRT (Define.xml), Reviewers Guide, and Pinnacle 21 reports
• Interpret and provide support for CDISC SDTM integration studies (ISS/ISE) as well as COVID-19 considerations such as re-screened subjects, missed visits, subjects continuing into extension study or multiple studies
• Maintained over 50% billable utilization, while performing direct line management of nine staff members across North America (USA) and Europe (France and United Kingdom) 7 full-time and 2 part-time employees
• Provide general infrastructure support by giving presentations at department meetings, contributing to other general department documents or policies, and assisting with internal web-page/wiki development
• Ensured compliance with industry regulations and legal requirements by implementing comprehensive policies and training programs for staff members
• Mentored junior team members for career advancement, fostering pipeline of future leaders within organization
• Developed and maintained relationships with internal and external customers through account development

PERFORMANCE AWARD

• PPD CEO Defining Principles Award: Moderna COVID-19 (2021)

• Led and supervised programming team in use of database from innovative Science 37 decentralized clinical trials operating system to client-specific controlled terminology (CT) and CDISC SDTM mapping
• Maintained over 60% billable utilization while performing direct line management of 3 staff members located across North America (USA and Canada)
• Responsible for supervision and management of statistical programming staff including hiring, motivation, training, coaching/mentoring, and performance evaluation
• Increased knowledge base and professional skills of staff in areas including programming technology and techniques, clinical trials, and pharmaceutical industry through on job training, mentoring, and internal or external training courses
• Worked with staff to develop short- and long-term career development goals
• Identified, advocated for, and was granted accelerated promotion of staff member who was hired at position lower than was merited by their technical expertise
• Core team member responsible for beta-testing, and subsequently training global company-wide staff during conversion from stand-alone SAS to SAS GRID (via SAS Studio and SAS Enterprise Guide), to include modernization upgrades to proprietary version-control infrastructure and programming environment
• Worked to increase visibility of PPD by encouraging staff to participate, or to personally participate in publication of articles in industry journals and presentations at conferences
• Interviewed candidates at all levels and provide hiring, retention, and remuneration advice
• Drove innovation by researching and proposing new technologies, leading to successful adoption of cutting-edge tools and practices

PERFORMANCE AWARDS

• PPD Delta Site Peer Award: SDTM Guru (2020)
• PPD Exceptional Performance Award: Receptos (2018)

• Served as Lead Statistician or Senior Reviewer on multiple projects of large size and complexity or on multiple-protocol programs
• Aided in development of protocols by writing statistical portion of protocols, providing sample size calculations and reviewing protocols for consistency
• Wrote statistical analysis plans (SAP) for various projects and statistical reports
• Provided programming specifications for Tables, Listings and Figures (TLF), CDISC-compliant ADaM datasets or analysis datasets (ADB)
• Oversaw programming development and assured completeness, accuracy and statistical validity and integrity of TLFs used for preparation of clinical study reports (CSRs), abstracts, and manuscripts
• Programmed and validated statistical outputs with emphasis on efficacy endpoints
• Served as statistical liaison for clinical and market development project management teams, multi-departmental internal teams, and sponsors
• Tracked and managed timelines, and budgetary issues for projects
• Communicated deadline and budgetary deviations as identified
• Developed bids and contract modification costs for studies
• Aided business development with statistical considerations for new study bids, wrote bid text, prepared biostatistics budgets, and attended bid defense meetings
• Mentored junior statisticians and new staff members

PERFORMANCE AWARD

• PPD CEO Teamwork Excellence Award: Millennium (2015)

• Senior Research Data Management Coordinator - University of Texas Health Science Center (UTHSCSA)
• Marketing Analyst - Sigma Marketing Group
• Health Care Outcome Analyst - University of Rochester (Strong Health)
• Senior Psychometrics Data Analyst - Harcourt Assessment
• Senior Psychometrics Data Analyst - Pearson Educational Measurement
• Public Affairs Analyst - South Texas Veterans Health Care System (STVHCS)