Associate Director, Statistical Programming

Job Description Summary

The 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.

 

Job Description

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)

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-culture

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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Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Programming Languages, Reporting, Statistical Analysis, Waterfall Model