Associate Director, Statistical Programming
$150,000–$195,000 year
HybridSan Diego, California, United States
Job Summary
Develop statistical programming processes, maintain SOPs, and lead projects to ensure timely, accurate deliverables for clinical development programs. Program analysis datasets, tables, figures, and Integrated Summaries for submissions including DSUR, PSUR, and IB. Review and generate SDTM, ADaM, and Define.xml files along with supporting documentation. Provide validation support for clinical study reports and oversee external vendors such as CROs. Develop and review SAPs, case report forms, and validation plans while coordinating programming activities with Biometrics leads and data managers. Apply programming methodologies to support the clinical development process and ensure compliance with CDISC, ICH, and FDA guidelines. Manage complex project plans, timelines, and budgets within a cross-functional team environment.
Required Qualifications
- Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline
- Minimum 8 years' experience in clinical research
- Experience as a SAS programmer for phase I-IV clinical trials in a pharmaceutical/CRO environment
- 3-5 years of progressive leadership experience
- At least 3 years' experience as Lead Programmer
- Technical knowledge and experience with SDTM, ADaM, and Define.XML
- Strong understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP)
- Submission support with compliance experience
- Thorough knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS)
- Experience with MS Office
- Proven experience with UNIX and Windows operating systems
- Understanding of the software development life cycle
- Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity
- Strong interpersonal and organizational skills
- Excellent verbal and written communication skills
- Successful record of creating and managing complex project plans, timelines, budgets and critical paths
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Ability to perform face to face work with colleagues and/or onsite in San Diego
- Must be available for onsite work in San Diego (No role is expected to be 100% remote)
Desired Qualifications
- Masters preferred
- Experience in managing vendors and/or direct reports
- Familiarity or experience with R Software
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork
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