Shelley Dunn
San Marcos,CA
Summary
Experienced executive leader with a proven track record of driving organizational success and fostering collaboration. Skilled in strategic planning, financial oversight, and stakeholder engagement. Recognized for adaptability, resilience, and consistently delivering results in evolving environments. Strong interpersonal skills, effective communication abilities, and a results-driven approach.
Established and built a biometrics programming department while collaborating on FDA submissions. Extensive knowledge in software development and recognized as a leader in biometrics server implementation. Expertise as a CDISC subject matter expert.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Executive Director, Statistical Programming
Travere Therapeutics
09.2023 - Current
- Provide strategic input and leadership to the delivery of statistical programming contributions across all clinical development projects
- Responsible for the delivery of the technical components required to support the analysis and reporting for clinical development projects
- Develop processes, SOPs, and work instructions
- Maintain company culture by supporting equality, diversity, and including within company and rare disease community
- Manage a diverse team of professionals, fostering a collaborative work environment for increased productivity.
- Negotiate contracts with vendors, securing favorable terms while adhering to budgetary constraints.
- Establish and maintain strong relationships with customers, vendors and strategic partners.
- Manage programmers and contribute to the professional development of Biometrics personnel by conducting trainings and coaching
Senior Director, Statistical Programming
Travere Therapeutics
08.2020 - 09.2023
Director, Statistical Programming
Travere Therapeutics
09.2017 - 08.2020
Director, Biostatistical Programming
Regulus Therapeutics
02.2016 - 05.2017
- Served as programming director and lead on all clinical projects
- Oversaw and coordinate deliverables with CROs, contractors, pharmacovigilance providers, outside vendors, and internal clinical, medical, and regulatory groups
- Establishing SAS programming environment and infrastructure
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Interacted well with customers to build connections and nurture relationships.
- Demonstrated strong organizational and time management skills while managing multiple projects.
Senior Life Sciences Consultant
d-Wise
12.2013 - 02.2016
- Engage with life science customers to develop clinical data standards and the associated business processes and governance to support the standards
- Prepared client assessments on standards development and CDISC knowledge through interviewing team members and reviewing documentation
- Created customized SDTM and ADaM workshop training modules and deliver onsite training to sponsors
- Served as co-lead of the ADaM compliance sub-team, worked with team to develop validation checks based on current ADaM documents, and publish updated version on CDISC web site
Life Sciences Consultant
d-Wise
12.2012 - 12.2013
Associate Director, Statistical Programming
Synteract, Inc.
06.2012 - 12.2012
- Led teams, supervising daily performance as well as training and improvement plans.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within the company.
- Led all aspects of submissions for clients
- Developed CDISC Committee to disseminate information to department and establish internal procedures
Senior Manager, Statistical Programming
Synteract, Inc.
01.2010 - 01.2012
Manager, Statistical Programming
Synteract, Inc.
01.2006 - 01.2010
Senior Statistical Programmer
Synteract, Inc.
01.2005 - 01.2006
Education
Master of Science - Mathematics
University of New Hampshire
Durham, NHBachelor of Science - Mathematical Sciences – Statistical Emphasis
University of California at Santa Barbara
Santa Barbara, CABachelor of Arts - Sociology
University of California at Santa Barbara
Santa Barbara, CAClinical Trials Certification -
University of California at San Diego Extension
San Diego, CASkills
- Program leadership
- Staff management
- Budgeting and financial management
- Dynamic Speaker
- Strategic planning
- Educator
- FDA Submissions
- CDISC
- Programming and validation
- Phase I-IV Clinical Trials
- Software development
- Server implementation
Therapeutic Experience
- Genetic and Rare Diseases: Alport Syndrome, PKAN, FSGS, IgAN, CTX, Cholestatis, HCU
- CNS: Insomnia, Post-Surgical Pain, Alzheimer’s
- Endocrine: Gout, Diabetes
- Hepatology: Hepatitis C
- Ophthalmic: Eye Pain
- Oncology: Melanoma, Bladder Cancer
Certification
- SAS Certified Base Programmer
- Clinical Trials Certification, University of California at San Diego Extension, San Diego, CA
Publicationspresentations
- The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future, Shelley Dunn, Ed Lombardi, PharmaSUG, 05/15
- How Valued is Value Level Metadata, Shelley Dunn, PharmaSUG, 06/14
- Therapy Lessons Learned to Empower Programmers, Shelley Dunn, PharmaSUG, 05/13
Awards
- Best Paper Award in Data Standards, PharmaSUG, 05/15
- Best Paper Award in Data Standards, PharmaSUG, 06/14
Timeline
Executive Director, Statistical Programming
Travere Therapeutics
09.2023 - Current
Senior Director, Statistical Programming
Travere Therapeutics
08.2020 - 09.2023
Director, Statistical Programming
Travere Therapeutics
09.2017 - 08.2020
Director, Biostatistical Programming
Regulus Therapeutics
02.2016 - 05.2017
Senior Life Sciences Consultant
d-Wise
12.2013 - 02.2016
Life Sciences Consultant
d-Wise
12.2012 - 12.2013
Associate Director, Statistical Programming
Synteract, Inc.
06.2012 - 12.2012
Senior Manager, Statistical Programming
Synteract, Inc.
01.2010 - 01.2012
Manager, Statistical Programming
Synteract, Inc.
01.2006 - 01.2010
Senior Statistical Programmer
Synteract, Inc.
01.2005 - 01.2006
Bachelor of Science - Mathematical Sciences – Statistical Emphasis
University of California at Santa Barbara
Bachelor of Arts - Sociology
University of California at Santa Barbara
Clinical Trials Certification -
University of California at San Diego Extension
Master of Science - Mathematics
University of New Hampshire
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