Director, Statistical Programming

Main Responsibilities and Accountabilities

• Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high quality, timely, delivery. Ensure realistic resource planning.
• Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis.
• Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other ad-hoc requests.
• Manages, hires, and mentors direct reports including annual evaluations and goal setting.
• As a member of the programming leadership team within biometrics, creates, maintains ensures compliance with programming process and strategy to facilitate accurate and timely analysis programming.
• Help bring state of the art programming methods and tools to the organization and drive automation of delivery, including AI.
• Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality.
• Represents the company in outside professional organizations and meetings.

Job Qualifications and Experience Requirements

• Education: BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
• Experience: At least 10 years of experience in the biotech, pharma, or CRO industries; Preferred 5 or more years of direct supervisory experience; Experience with CRO management and/or CRO work experience; Extensive understanding of clinical programming and/or statistical programming processes and standards; Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros, preferred managing team performing these activities as well; Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM); Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines; Experience in working in cross-functional, multicultural and international clinical trial teams