AMY T. CRAVEN
Summary
Dynamic Statistical Programming Leader driving operational excellence in clinical trial analysis and dataset development. Successfully managed cross-functional teams to deliver timely, high-quality programming deliverables that supported regulatory submissions, fostering a collaborative environment that prioritized professional growth and process improvement.
Overview
1
1
Certification
6
6
years of post-secondary education
26
26
years of professional experience
Work History
Manager, Statistical Programming
Catalyst Clinical Research
05.2021 - Current
- Managed a staff of 6+ SAS programmers in support of Statistical programming activities.
- Oversaw programming functions for generating statistical analyses, including TLF generation within the Biometrics group.
- Facilitated technical expertise with internal and external teams to design, implement, validate, and maintain project reporting applications aligned with departmental standards.
- Coordinated programming efforts among team members to enhance workflow efficiency and meet project deadlines.
- Monitored performance and identified training and development needs to support team growth and skill enhancement.
- Assist in the development and communication of departmental policies and procedures.
- Created safety and efficacy SAS datasets.
- Created macros and formats tailored to specific project requirements for efficiency.
- Conducted data checks to verify structure and content of data.
Senior Programmer
ICON Early Phase Services
06.2019 - 05.2021
- Led statistical programming projects, overseeing and coordinating activities for multiple assigned projects and complex studies.
- Resolved complex technical problems, led specialized biostatistics development projects, and provided statistical programming input to streamline work processes and enhance cross-functional collaboration.
- Liaised during clinical studies between biostatistics, statistical programming, and study sponsor to ensure timely programming deliverables and address sponsor requests.
- For multiple projects, work closely with the clinical teams, study sponsor, data manager, project management, statisticians and programmers to analyze and present data based on sponsor specifications and CDISC guidelines.
- Create specifications and programs for traditional derived SAS datasets and CDISC ADaM datasets.
- Produce and validate SAS programs for analyses, tables, listings and graphs, while ensuring that all quality control procedures are followed.
- Provided technical support and training to colleagues, mentoring team members while assisting management with interviewing and hiring decisions.
Manager SAS Data Programming
IQVIA Biotech
06.2017 - 06.2019
- Managed and supported staff of 5+ SAS programmers for SDTM programming activities, ensuring timely project delivery.
- Managed project programming activities to ensure all deliverables met deadlines.
- Developed specifications and test data for custom data files and data integration for Sponsor, updating blank CRFs with custom annotations to enhance data quality.
- Developed specifications and test data for custom data files and data integration; updated blank CRFs with custom annotations.
- Develop specifications and test data for SDTM. Program and generate reports to facilitate vendor reconciliation and medical coding.
- Develop specifications and programs to integrate local lab normal ranges with data extract.
- Conducted annual employee performance reviews to evaluate staff contributions and development needs.
Senior Programmer
ICON Early Phase Services
03.2014 - 06.2017
- Led statistical programming projects, overseeing and coordinating programming activities for multiple assigned projects and complex studies.
- Liaised during clinical studies between biostatistics, statistical programming, and study sponsor to ensure high-quality, timely programming deliverables while addressing sponsor requests.
- Resolve complex technical problems, research and assist in technical and procedural advancements, lead specialized Biostatistics development projects, and interact with other departments giving statistical programming input to streamline work processes and enhance cross-functional workflow.
- For multiple projects, work closely with the clinical teams, study sponsor, data manager, project management, statisticians and programmers to analyze and present data based on sponsor specifications and CDISC guidelines.
- Create specifications and programs for traditional derived SAS datasets and CDISC ADaM datasets.
- Resolved complex technical problems, researched and assisted in procedural advancements, led specialized biostatistics development projects, and collaborated with departments to streamline work processes and enhance cross-functional workflow.
- Provided technical support and mentoring to colleagues, and assisted management with interviewing and hiring decisions.
Principal Programmer/Line Manager
Quanticate
08.2013 - 03.2014
- Managed a team of 6 as the line manager and site head.
- Led process improvements and facilitated knowledge-sharing initiatives within the function to enhance team collaboration.
- Provided advanced project and technical support in the preparation and review of high-quality programming deliverables and documentation.
- Facilitated knowledge-sharing activities to promote best practices within the team.
- Provided mentoring and leadership of staff.
- Participated in recruitment, business development, and audit meetings, contributing programming insights to inform decision-making.
- Supported recruitment and retention of staff within Quanticate.
Senior SAS Programmer Analyst
ICON Clinical Research
03.2012 - 08.2013
- Led statistical programming projects and coordinated activities for multiple assigned projects and complex studies.
- Liaised during clinical studies between biostatistics, statistical programming and study sponsor, ensuring timely programming deliverables and addressing sponsor requests.
- For multiple projects, work closely with the clinical teams, study sponsor, data manager, project management, statisticians and programmers to analyze and present data based on sponsor specifications and CDISC guidelines.
- Produce and validate SAS programs for analyses, tables, listings and graphs, while ensuring that all quality control procedures are followed.
- Create specifications and programs for traditional derived SAS datasets and CDISC ADaM datasets.
- Resolved complex technical problems, led specialized biostatistics development projects, and collaborated with other departments to streamline work processes and enhance cross-functional workflow.
- Provided technical support, training, and mentorship to colleagues while assisting management with interviewing and hiring decisions.
Senior Statistical Programmer
Synteract, Inc.
07.2011 - 03.2012
- Delivered specialized knowledge and support for statistical and clinical programming activities in clinical research studies, enhancing data integrity and compliance.
- Reviewed and maintained requisite study documentation; designed, developed, tested, and maintained programs for the analysis and reporting of clinical trial data ensuring completion of all activities with high quality per project timelines.
- Provided specialized knowledge and support to carry out statistical and clinical programming activities in support of clinical research studies.
- Performed programming validation and quality control according to company SOPs.
- Created and maintained tables/listings/graphs using SAS.
- Reviewed and maintained study documentation; designed, developed, tested, and maintained analysis programs for clinical trial data, ensuring high-quality completion within project timelines.
- Provided guidance and mentoring to peer and junior programmers in programming methodologies; assisted management with interviewing and hiring decisions.
Statistical Programmer
i3 Statprobe
10.2010 - 07.2011
- Led statistical programming efforts as technical expert on project teams, ensuring adherence to project timelines and quality standards.
- Planned, wrote, and executed statistical programs designed to analyze clinical trial data, including any or all of the following: analysis datasets, tables, listings, and graphs.
- Coordinated and maintained comprehensive statistical programming documentation to support project transparency and compliance.
- Maintained, verified and ensured the quality and accuracy of all assigned statistical output and project requirements.
- Coordinated, created, and maintained statistical programming project documentation.
- Provided guidance and support to junior staff to enhance their skills and knowledge.
- Facilitated transfer of deliverables to internal and external sponsors, ensuring accuracy and timeliness in accordance with project requirements.
- Complied with regulatory requirements and company standards.
Statistical Programmer
PAREXEL International
12.2006 - 10.2010
- Used SAS software in the production derived datasets tables, figures and data listings and other statistical analyses for clinical trials.
- Conducted QC of derived datasets, tables, figures, and data listings to ensure accuracy and compliance with project standards.
- Coordinated and led project teams to successful completion of projects within given timelines and budget.
- Created standard macros and applications to improve the efficiency of the department.
- Mentored and trained junior members of the department.
- Coordinated and led project teams to successful completion of projects within given timelines and budget.
- Developed standard macros and applications that streamlined processes and enhanced departmental efficiency.
- Coordinated development of client proposal documents.
Statistical Programmer
Constella Group
05.2005 - 12.2006
- Implemented pre-specified data analysis plans and performed data manipulation and reporting tasks using SAS or other statistical software.
- Implemented pre-specified data analysis plans and performed data manipulation and reporting tasks using SAS or other statistical software.
- Created and managed project-specific data sets to facilitate targeted analysis and reporting.
- Evaluated data reliability and validity, wrote and executed SAS programs for data manipulation, analysis, and summary to ensure accuracy of results.
Research Associate
Measurement, Inc.
05.2000 - 05.2005
- Conducted statistical analysis and validation studies for achievement tests being administered and/or being developed in various states under the supervision of a Senior Psychometrician.
- Managed the development, maintenance and analysis of Excel and Access item banks for multiple projects.
- Verified accuracy of test keys during the validation process.
- Managed development, maintenance, and analysis of Excel and Access item banks, supporting multiple projects and enhancing data accessibility.
- Produced project summaries and reports as well as worked with test developers to create test forms.
- Produced project summaries and reports, collaborating with test developers to create effective test forms.
- Facilitated collaboration with program managers to ensure project alignment.
Education
Certificate - International Biomedical Regulatory Sciences
University of Georgia
Athens, GA 08.2017 - 07.2018
MBA - Business Administration
Liberty University
Lynchburg, VA 08.2006 - 12.2008
B.S. - Psychology, Sociology
Virginia Polytechnic Institute & State University (Virginia Tech)
Blacksburg, VA 05.1995 - 05.1998
Skills
- SAS programming
- CDISC compliance
- Data validation
- Macro development
- Regulatory adherence
- Project management
- Process improvement
- Technical documentation
- Team coordination
- Cross-functional team management
- Problem solving
- Training and mentoring
- Effective communication
Certification
- SAS Certified Base Programmer for SAS9
- Six Sigma Yellow Belt
Timeline
Manager, Statistical Programming
Catalyst Clinical Research
05.2021 - Current
Senior Programmer
ICON Early Phase Services
06.2019 - 05.2021
Certificate - International Biomedical Regulatory Sciences
University of Georgia
08.2017 - 07.2018
Manager SAS Data Programming
IQVIA Biotech
06.2017 - 06.2019
Senior Programmer
ICON Early Phase Services
03.2014 - 06.2017
Principal Programmer/Line Manager
Quanticate
08.2013 - 03.2014
Senior SAS Programmer Analyst
ICON Clinical Research
03.2012 - 08.2013
Senior Statistical Programmer
Synteract, Inc.
07.2011 - 03.2012
Statistical Programmer
i3 Statprobe
10.2010 - 07.2011
Statistical Programmer
PAREXEL International
12.2006 - 10.2010
MBA - Business Administration
Liberty University
08.2006 - 12.2008
Statistical Programmer
Constella Group
05.2005 - 12.2006
Research Associate
Measurement, Inc.
05.2000 - 05.2005
B.S. - Psychology, Sociology
Virginia Polytechnic Institute & State University (Virginia Tech)
05.1995 - 05.1998