Summary

The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and belongs to the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum. In this role, you will be responsible for all statistical programming aspects of Early Development Oncology (which could cover multiple therapeutic/Disease areas(DA)). This role may involve being a people manager, leading multiple Disease area, or both This role is expected to have extensive functional experience and knowledge about drug development, GCP, regulatory requirements but more importantly, should have experience in Industry standards and SAS/R programming. Bringing experience and expertise to develop the TA/disease area knowledge and capabilities within their team to meet the demands of the portfolio for that specific AQS Development Unit/sub-function. They will work with key functional stakeholders within AQS and other areas to enhance TA specific knowledge and understanding, with a focus on meeting project deliverables with high quality and efficiency. This role is that of an influential leader, representing Statistical Programming at leadership meetings with direct, oversight and coordination of all functional activities, to meet portfolio requirements.

• Drives productivity and efficiency measures to meet the strategic imperatives within AQS Early Development Oncology team, quality and productivity targets. Actively ensures that team's performance measures are being met or exceeded. Takes appropriate action when needed to drive corrective measures.
• Establish and steer a business founded on disease area knowledge, innovation, collaboration, quality, and trust.
• Evaluate Statistical Programming requirements of computer systems and needs that relate to programming and reporting activities that foster use of emerging technologies in an innovative but compliant manner.
• As a functional leader of AQS, acting with an enterprise mindset, is fully involved in all aspects of Statistical Programming including the development of future strategies and processes. Contributes to the further development of the AQS organization with a focus on continuous improvement and quality by fostering statistical programming innovations, processes and solutions that ensure efficient implementation and knowledge sharing across Novartis.
• Understands the needs and expectations of the different Health Authorities, ensures audit readiness and participates in Health Authority inspections. Monitors all assigned projects within Early Development Oncology, complying with Novartis, AQS and industry standards (e.g. CDISC) and processes.
• Identify the need for enhanced capability programs (R programming, Disease Area skills etc.) and support the establishment of technical, business, and soft skills for all Statistical Programming associates.
• Leads and supports global clinical and non-clinical projects and initiatives to drive functional excellence within AQS,
• Ensures high quality communication and information flow on status of all deliverables to stakeholders, mitigates and manages risks

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 6+ years in a programming or statistical role.
• 7+ years' experience in a line management or equivalent leadership experience, such as matrix management (applicable for people managers only). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple simultaneous deliverables, ensuring deadlines are met.
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP).
• Ability to engage in strategic discussions with stakeholders on initiatives that have the potential to boost the efficiency of clinical trials and that decision-enabling analyses for Early Development Oncology are delivered.
• All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures.
• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.

• Ideally 12 years' experience in Drug Development with at least 10 years' in Statistical Programming.