Job Description Summary
The Early Development, Associate Director, Statistical Programming, is responsible for all statistical programming aspects of one or more drug development programs or indication programs within the Early Development space.
As a program lead, the Associate Director ensures cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug lifecycle management. They ensure that the trials/programs 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, experience in regulatory activities, and expertise in statistical reporting, along with a proven track record in operational or functional leadership, are required.
Responsibilities:
1. Lead statistical programming activities for multiple clinical trials within a program or indication/disease area.
2. Coordinate activities of internal/external programmers. Make statistical programming decisions and propose strategies at the program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area with the Biostatistician(s).
3. Allocate resources within a program and ensure resource sharing between programs to meet organizational goals.
4. Recruit, mentor, and evaluate statistical programmers. Conduct performance appraisals of direct reports, as applicable.
5. Build and maintain effective working relationships with cross-functional team members, and communicate the status of deliverables and critical programming aspects effectively.
6. Maintain up-to-date knowledge of programming software (e.g., SAS/R) and industry standards (e.g., CDISC, eCTD, Define.xml). Attend functional meetings and training.
7. Represent SP (Early Development) at audits/inspections, Health Authority meetings, and external conferences or consortiums (e.g., CDISC).
Experience and Qualifications:
* Deep understanding of clinical trial methodology, regulatory requirements, and GCP. Proven leadership, collaboration, and organizational skills to manage multiple trials effectively.
* BS/MS in life sciences, computer science, statistics, mathematics, or relevant field. Fluency in English.
* Early development experience, preferably in Oncology.
* Excellent interpersonal skills for effective operation in a global environment and communication across functions.
* Expertise in SAS or R programming, including development and validation of deliverables and creation of advanced MACROs/functions.
* Experience managing a team of approximately 6-15 programmers. May act as a functional/operational manager or individual contributor.
* Advanced knowledge of industry standards, including CDISC, and standard program development.
* Minimum of 2+ years as a Lead/Program/Project Programmer, coordinating large teams, with ideally 10+ years of industry experience and 6+ years in a programming or statistical role. At least 3 years of leadership experience.
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Skills Desired:
Classification Systems, Clinical Trials, Data Storage, Programming Languages, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Reporting, Statistical Analysis, Waterfall Model
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