Office Location: London (The Westworks), United Kingdom
Hybrid (12 days per month on-site if living within 50 miles of our London office)
Remote (if living beyond 50 miles of our London office)
The Associate Director, Statistical Programming , is responsible for all statistical programming aspects of one or more drug development programs or indication programs or 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 life cycle management. They ensure that the assigned 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, is required.
Major Accountabilities
- Lead SP activities for multiple clinical trials within a program or an indication/disease area.
- Experience in one of the TA areas: Immunology, Cardiovascular & Metabolic Diseases and Neuroscience is must.
- 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 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 (Early Development) 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).
Minimum 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 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 early development experience, ideally in Oncology.
- 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 6-15 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.
- 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, extensive years of industry experience, with at least experience in a programming or statistical role.
- Experience of line management or equivalent leadership experience, such as matrix management (applicable for people managers only).
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.
#J-18808-Ljbffr…