Key Responsibilities

• Lead SP activities for multiple clinical trials within the assigned Therapeutic Area. Experience in one of the TA(s) :  Cardiovascular & Metabolic Diseases and Neuroscience is must.
• Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at TA level. Develop/review scientific documentation for the program(s) or indication/disease area within the assigned TA together with the Biostatistician(s).
• Responsible for allocating resources within a TA and ensuring resource sharing between programs to meet Advanced Quantitative Science and organizational goals.
• Recruit, mentor, and nurture statistical programmers. Conduct performance appraisal of direct reports, as applicable.
• 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 SP (Medical Affairs) at TA level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC).

Essential Requirements:

• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials, Publication/Manuscript requests and other Exploratory Analysis simultaneously, ensuring deadlines are met.
• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree. Must also be fluent in English
• Must have some Medical Affairs experience, ideally in Neuroscience or CRM.
• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.
• 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.
• Matrix or people management of approximately 10-20 internal or external programmers. Depending on role, may act as a functional/operational manager of associates or may be an individual contributor with no direct reports.
• 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. Ideally, 10+ years of industry experience, with at least 6 years in a programming or statistical role. At least 3 years of line management or equivalent leadership experience, such as matrix management (applicable for people managers only)

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Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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