Assoc Director, Statistical Programming

Job Description Summary

#LI-Onsite
East Hanover, New Jersey

About the role:
The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and part of the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum. In this role, you will be responsible for all statistical programming aspects of one or more drug development programs or indication programs. This role may involve being a people manager, a program lead, or both. You will lead cross-functional collaboration within and outside AQS 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. This includes, but is not limited to, consulting on pooling strategies, acting as a subject matter expert (SME) at audits/inspections, and leading technical non-clinical initiatives.

 

Job Description

Your Key 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.
   

Video Link  https://www.youtube.com/watch?v=vUAhCMIZbys
 

This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely.

Role Requirements:
Essential Requirements:   

• 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 progr