Executive Director, Statistical Programming

About the role

The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department and will work closely with the head of Biometrics in identifying project programming demands and resource needs. The ideal candidate will provide hands-on support to project teams by carrying out and conducting programming activities, leading statistical programmers, and coordinating with external vendors, Statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies.

Responsibilities

• Serve as head of the Statistical Programming function within the Biometrics Department.
• Provide strategic input and leadership to the delivery of statistical programming contributions across all clinical development projects.
• Overall accountability of programming deliverables required to support the analysis and reporting for clinical development projects.
• Provide statistical programming and validation support for clinical study reports and coordinating programming activities among the study programmers to achieve timely progress in the following areas: 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).
• Lead and contribute to the development and review of case report forms, clinical DB specifications, SAP, reporting and analysis datasets specifications, validation plans, and TLFs.
• Ensure quality of all project programming deliverables.
• Lead the development and maintenance of programming-related SOPs, work practice documents, technical standards, and programming specification documents.
• Ensure that Biometrics systems and processes are up to date in terms of scalability, connectivity, and security, in collaboration with IT and QA.
• Manage or provide oversight to third party service providers (i.e., contractors or CROs). Conduct vendor qualifications and GCP audits (in collaboration with QA), as appropriate.
• Identify and lead the application of programming methodologies to support all aspects of the clinical development process. Leverage programming tools to convert data into information to enable decision making. Identify the need for and lead the development and maintenance of applications used for analysis and reporting.
• Manage programmers and contribute to the professional development of Biometrics personnel by conducting trainings and coaching.
• May represent the Biometrics Department in cross-departmental initiatives and projects (e.g., process and quality improvements).

Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline required. Masters preferred.
• 14+ years of experience in clinical SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment, with at least 7 years in a leadership or management role.
• Strong technical skills and experience supporting submissions are required.

Additional Skills/Experience

• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment.
• Extensive experience in managing vendors and direct reports.
• Extensive technical knowledge and experience with SDTM, ADaM, and Define.XML.
• Strong understanding of the drug development process, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
• Submission support with compliance experience.
• Advanced 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 or Windows operating systems.
• Strong understanding of the software development and maintenance life cycle.
• Ability to effectively communicate and perform in a high demand and dynamic working environment.
• Ability to travel 10% domestically and internationally.