Associate Director Statistical Programming

Role Summary

Onsite in East Hanover, New Jersey. The Associate Director Statistical Programming leads all statistical programming aspects for one or more drug development programs or indications within the Advanced Quantitative Sciences organization. The role may involve being a people manager, a program lead, or both, and requires cross-functional collaboration and decision-making for assigned trials/programs in drug life cycle management and efficient, timely execution of integrated/clinical development/evidence plans. You will also take on strategic technical roles across programs or at an enterprise level, including consulting on pooling strategies, acting as a subject matter expert at audits/inspections, and engaging with industry working groups and organizations.

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

• Required: BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 6+ years in a programming or statistical role.
• Required: 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.
• Required: In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP).
• Required: 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.
• Required: Significant experience in contributing to statistical analysis plans and developing technical programming specifications.
• Required: Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs.
• Required: 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.
• Required: Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.
• Preferred: 10+ years experience in a programming or statistical role equivalent.

Education

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