Associate Director, Statistical Programming

Position Summary

Position Summary: The Associate Director, Statistical Programming works closely with the Executive Director, Statistical Programming and other members of the Biometrics team to provide programming support across all programs. The ideal candidate will provide hands-on programming and validation support to project teams and oversee external vendors to ensure timely and accurate deliverables. This role will also provide technical expertise to development programming standards and procedures and will work cross-functionally.

Strong technical skills and experiences supporting submissions are required.

• Provides strategic input regarding the development of statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.
• Assists in the development of programming standards and tools to improve the efficiency and accuracy required to support the analysis and reporting for clinical development projects.
• Lead projects/studies, oversee contractors, and ensure quality and timeliness of programming deliverables.
• Program analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications, responses to regulatory questions).
• Reviews/Develops CDISC specifications and review/generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation for submissions.
• Provides statistical programming and validation support for clinical study reports, oversee external vendors (e.g., CROs), and coordinate programming activities with Biometrics lead, data managers, and other study programmers.
• Develops and/or reviews SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
• Provides input on the application of programming methodologies to support the clinical development process.

• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline. Masters preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 8 years' experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
• 3-5 years of progressive leadership experience with at least 3 years' experience as Lead Programmer is required.

• Experience in managing vendors and/or direct reports.
• 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) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
• 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 multitask and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Successful record of creating and managing complex project plans, timelines, budgets and critical paths.

Compensation based on level/skill - target $150-195K