Associate Director Statistical Programming

Role Summary

Associate Director Statistical Programming role based in East Hanover, New Jersey. Responsible for all statistical programming aspects of one or more drug development programs or indication programs, potentially including people management or program leadership. Leads cross-functional collaboration, decision-making for trials, and strategic technical roles across programs or at enterprise level.

Responsibilities

• Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program.
• Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s).
• Responsible for allocating resources within a program and ensuring resource sharing between programs to meet AQS and organizational goals.
• May act as an operational and/or functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes.
• Recruit, mentor, and develop statistical programmers.
• Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan).
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training.
• Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC).
• Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives.

Qualifications

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 10+ year in drug development with 6+ years in a programming or statistical role.
• 3+ years experience in a line management or equivalent leadership experience, such as matrix management (applicable for people managers only).
• Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met.
• Accountable for timely and quality development and validation of all statistical programming components on assigned project(s). Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports to ensure high quality performance across their community of Statistical Programmers
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
• Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions.
• Significant experience in contributing to statistical analysis plans and developing technical programming specifications.
• Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs.
• At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers.
• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.

Skills

• SAS or R programming
• CDISC standards
• Statistical programming deliverables development and validation
• Resource planning and cross-functional collaboration
• Mentoring and leadership of programmers
• Audit readiness and regulatory compliance

Education

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree