Summary

• SAS programmer with over 13 years of experience in clinical research, including positions in data management, statistical programming, and management at a central laboratory, a pharmaceutical company, and CROs.
• Expertise in CDISC, including CDASH, LAB, SDTM, ADAM, and CRT-DDS define.xml models and with regulatory submissions, including integrated summaries of safety and efficacy ISS/ISE and safety updates.
• Experience with data standards libraries/metadata repositories.
• Experience working with global teams and working remotely.

Experience

• inVentiv Health Clinical formerly PharmaNet/i3, i3 Statprobe home-based in Hebron, KY
• Associate Director, Statistical Programming
• Head of global SDTM team within a FSP. Projects include legacy conversions as well as in flow conversions, plus submission-ready files and documents. Close partnership with sponsor in efforts to develop end-to-end processes utilizing data standards, including standards library, and collaboration with data management and statistical teams to ensure smooth transition and hand-offs from data collection through data analysis and reporting.
• Full responsibility for all aspects of partnership management, including project management and delivery, resource forecasts and allocation, financial performance, quality, communication, and risk management.
• Set and implement team strategy and direction in support of corporate objectives and client's strategy and pipeline.
• Ensure partnership contracts are understood and adhered to.
• Support the development and maintenance of partnership documents, which outline the processes to be followed in support of the partnership and contracts.
• Serve as main point of contact for operational management of the partnership, including issue escalation.
• Provide regular updates on partnership performance, including current risks/challenges, and ensure appropriate escalation of issues to senior management.
• Ensure project team members receive appropriate training and tools and are complying with appropriate operating procedures.
• Oversee development of direct reports, including performance evaluations, training needs, development plans, mentoring, and coaching.
• Ensure succession planning and development of associates to support growth of personnel and organization.
• Support management and business development efforts to expand existing partnership and identify new business opportunities.
• Lead or participate in corporate or department process initiatives.
• Identify and develop programming utilities using SAS.
• Oversee internal CDISC standards implementation, including leading internal CDISC teams, reviewing and assessing current processes and tools, making recommendations, and coordinating ongoing implementation, documentation, and training efforts.
• Serve as internal CDISC reviewer and project consultant.
• Represent inVentiv Health Clinical on CDISC's Advisory Council.
• Manager, Statistical Programming
• Recruit, hire, and supervise Statistical Programming associates.
• Conduct performance reviews and help develop and support ongoing associate development.
• Work directly with internal departments and clients in the definition, execution, and review of statistical programming projects.
• Assign resources to projects, communicate priorities, and oversee quality and timelines on Statistical Programming projects.
• Act as an authority in the field of statistical programming using SAS, provide statistical programming and other expert technical support to sponsors, programmers, and other department staff as needed.
• Oversee a large group of projects, including resourcing and assignments, timelines and priorities, budgets, interaction with other internal departments, and communication with the client.
• Coordinate and participate in the building, testing, and validation of tabulation and analysis datasets and the programming and validation of tables, listings, and figures using SAS.
• Assist with statistical quality assurance review. Review deliverables before transfer to internal or external clients.
• Help lead and contribute to strategic departmental development and mentorship activities, including training for department members.
• Provide leadership in the development of efficient programming processes within the department.
• Oversee internal CDISC standards implementation, including leading internal CDISC teams, reviewing and assessing current processes and tools, making recommendations, and coordinating ongoing implementation, documentation, and training efforts.
• Serve as internal CDISC reviewer and project consultant.
• Represent PharmaNet/i3 on CDISC's Advisory Board.
• Assist in sales and marketing efforts by providing input for proposals and contracts and attending bid defenses as requested.
• Principal Statistical Programmer
• Acted as an authority in the field of statistical programming using SAS, providing statistical programming and other expert technical support to sponsors, programmers, and other department staff as needed.
• Managed and led assignments and programming personnel on single and multiple projects.
• Coordinated and participated in the building, testing, and validation of tabulation and analysis datasets and the programming and validation of tables, listings, and figures using SAS.
• Assumed overall responsibility for the successful execution of projects including adherence to timelines and budgets, as well as the quality of deliverables.
• Worked directly with internal departments and clients in the definition, execution, and review of statistical programming projects.
• Assisted with statistical quality assurance review. Reviewed deliverables before transfer to internal or external clients.
• Helped lead and contribute to strategic departmental development and mentorship activities, including training for department members.
• Provided leadership in the development of efficient programming processes within the department.
• Co-led internal CDISC initiatives, including oversight of CDISC standards implementation reviewing and assessing current processes and tools, making recommendations, creation of strategic plan and coordinating ongoing implementation, documentation, and training efforts.
• Served as internal CDISC reviewer and project consultant.
• Oversaw all Statistical Programming work for a group of projects, including assignment of resources, working with the project manager to determine timelines and budgets, working with the sponsor to determine project priorities, and communicating internally to ensure that timelines were met with appropriate quality review.
• Participated in internal leadership programs with senior leaders to learn more about the organization, the industry, and to actively contribute to the company's strategic plans.
• Senior Programmer/Analyst, Biometrics
• Omnicare Clinical Research now part of Theorem Clinical Research

Confidential

Created and/or annotated and reviewed tables and listings mocks ensured internal consistency within and among tables and listings ensured that all CRF fields were displayed on listings.

Created SAS datasets of clinical data from clinical databases created status and efficacy datasets created project specific macros and formats loaded client data from other platforms and other software packages prepared data to be sent to clients.

Prepared documentation describing all datasets and variables within, including derived variables, and the project as a whole.

Performed data checks as needed, to ensure integrity and correctness of data displays. Prepared documentation for programs.

Programmed or QC'd customized data displays, including data listings, summary tables and routine graphics in accordance with approved statistical analysis plan and shell displays for clinical research studies. Code was written using Base SAS programs, SAS procedures, or standardized macros. Performed data checks as needed to understand structure and content of data.

Oversaw CDISC standards implementation, including reviewing and assessing current processes and tools, making recommendations, and coordinating ongoing implementation, documentation, and training efforts.

Served as internal CDISC resource and project consultant.

Confidential

Principal Statistical Programmer, Statistical Programming

• Managed projects or groups of projects, including scheduling work, ensuring compliance with timelines, budget, and quality, and functioning as an internal and external customer liaison.
• Functioned as Biometrics Project Lead on certain projects oversaw all Biometrics deliverables, including Clinical Data Management, Biostatistics, and Statistical Programming via interdepartmental communication, project meetings, and monitoring of internal and external project documentation .
• Coordinated and participated in the building, testing, and validation of clinical databases, the receipt and processing of external data, and the programming and validation of datasets, tables, listings, and figures using SAS.
• Assisted in development of the statistical analysis plan and table, listing, and figure mockups in conjunction with the statistician.
• Participated in internal teams which worked on creating and implementing company standards, including creating or modifying SOPs, work instructions, templates and job aids.
• Mentored and trained junior programmers and new hires.
• Assisted in sales and marketing efforts by providing input for proposals and contracts and attending bid defenses as requested.
• Participated in audits as required.
• Served as Global Lead for internal SDTM initiative and participated in internal global CDASH team.
• Senior Statistical Programmer, Statistical Programming
• Served as Biometrics contact with sponsors for clinical and statistical programming tasks.
• Coordinated and participated in the building, testing, and validation of clinical databases, the receipt and processing of external data, and the programming and validation of datasets, tables, listings, and figures using SAS.
• Ensured that programming deliverables datasets, tables, listings, and figures were sent to sponsors within the project timelines, that validation/quality control was performed on programs, and that output met quality standards and project requirements.
• Responsible for the coordination, creation, and maintenance of statistical programming budgets and documentation.
• Assisted in development of the statistical analysis plan and table, listing, and figure mockups in conjunction with the statistician.
• Trained and mentored junior programmers and led programming project teams.
• Served as Global Lead for internal SDTM initiative.
• Programmer II, Statistical Programming
• Created dataset specifications and annotated case report forms.
• Wrote and validated SAS programs to generate CRF datasets, derived datasets, tables, listings, and figures and for data cleaning and status reporting.
• Received and processed external data, including writing SAS programs to load the data, perform various file and data checks, and reconcile the data with source data.
• Coordinated with project management, data management, biostatistics, and medical writing groups in order to meet study milestones and produce deliverables within timelines.
• Participated on internal SDTM global initiative team.
• Consultant SAS Programmer and Project Manager
• COMSYS now part of Experis , contracted to Procter Gamble Mason, OH
• Consulted on development of new data standards system.
• Wrote SAS programs to load and store data in SAS datasets, perform merges, conversions and derivations, perform edit checks on the data, and generate reports.
• Created data dictionary.
• Created issue tracking/management system.
• Wrote SAS programs to generate custom reports from integrated study data for safety monitoring.
• Supervised other COMSYS consultants placed onsite at Procter Gamble provided orientation to COMSYS and Procter Gamble, reviewed and approved timesheets, hired and placed new consultants, monitored consultants' work to ensure quality .
• Medical Research Laboratories International
• Data Manager and Team Leader of Statistical Support Programming
• Worked with sponsors to create datasets, tables, and listings for data submissions to regulatory drug agencies.
• Scheduled projects and distributed assignments among a team of programmers.
• Responsible for supervisory tasks, including review and approval of timesheets, daily scheduling, training and mentoring, reviewing work, employee evaluations, hiring and termination decisions, and corrective actions.
• Collaborated and wrote programs to establish new internal CDISC standard format for transfer of central laboratory data.
• Asst. Data Manager, Data Transfer Team
• Transferred laboratory data pertaining to clinical research studies to pharmaceutical companies and/or CRO's.
• Performed quality checks on all data.
• Coordinated between several groups and oversaw various departments' progress in order to meet deadlines.
• Used SAS programming to create data files in format s specified by client.
• Mathematics/Statistics Instructor and Tutor

Confidential

• Taught introductory statistics and business algebra.
• Tutored students on individual and group basis in order to improve learning skills and subject-specific knowledge.

Papers and Presentations

• Reducing Variable Lengths for Submission Dataset Size Reduction , PharmaSUG 2014: San Diego, CA, June 2014.
• CDISC and the Study Team: Implementing CDISC from Protocol to CSR , PhUSE Single Day Event: Chicago, IL ,September 2012. Co-authored with Caryl Burke.
• SUPPQUAL Where's My Mommy , Midwest CDISC Users Group Meeting, May 2012.
• SUPPQUAL Where's My Mommy , SAS Global Forum 2012: Orlando, FL, April 2012.
• Validating define.xml: Tools, trials, and tribulations , PharmaSUG 2011: Nashville, TN, May 2011.
• Quality in a World of Standards with Differences , PharmaSUG 2010: Orlando, FL, May 2010.
• Issues and Ideas to Consider when Implementing SDTM for Integrated Data , CDISC 2008 International Interchange: Arlington, VA, Oct. 2008.