Associate Director, Statistical ProgrammingJob ID REQ-10053012May 23, 2025IrelandSummaryThe Medical Affairs, Associate Director, Statistical Programming, is responsible for all statistical programming aspects of one or more Therapeutic Areas (TAs) with Medical Affairs space.As a Therapeutic Area lead, the Associate Director ensures cross-functional collaboration within and outside Medical Affairs, Advanced Quantitative Science and decision-making for assigned Therapeutic Area in all the related Medical Affairs requests (CSRs, Regulatory submissions/Interactions, Safety reports, Pricing and Reimbursement requests, Publications, Post-Marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.They ensure that the assigned therapy areas are adequately resourced, and oversee all aspects of programming, quality, and regulatory compliance.This key leadership position ensures the efficient execution of trial/program level plans, delivering high-quality results on time. A thorough understanding of the drug development process along with Medical Affairs experience, experience in regulatory activities, and expertise in statistical reporting, along with a proven track record in operational or functional leadership, is required.About the RoleKey ResponsibilitiesLead 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).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 EnglishMust 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)Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? : https://www.novartis.com/about/strategy/people-and-cultureCommitment 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.Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkIE02 (FCRS = IE002) Novartis Ireland LtdFunctional Area Research & DevelopmentJob Type Full timeEmployment Type RegularShift Work NoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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