Job Description
• Strategic management of Statistical Reporting to ensure cutting edge/innovative processes and adequate allocation of technical capabilities across IIS • Ensure key partnerships outside of IIS (including external to Novartis) • Primary lead point of contact for statistical programming related initiatives within and outside of IIS 1. Develop and maintain high quality Statistical Programming standards globally across IIS 2. In collaboration with IIS Franchises, decide on the distribution of Statistical Programming resources across the IIS Franchises 3. Develop and maintain Functional Excellence for Statistical Reporting by defining strategic goals and leading the associated initiatives 4. Drive improvements in Statistical Reporting procedures through regular monitoring, review and update, including training methods and compliance 5. Ensure alignment of goals with the Clinical Data and Reporting Standards group 6. Work with IIS Program Heads, Team Leads in India, China, and Japan, as well as Chief Technical Officers in India to ensure that the required level of knowledge and skills within their groups and site is available. a. Define/drive technical training plans b. Ensure appropriate process and regulatory/external guidance training is available c. Promote collaboration and knowledge exchange, within and across Functional excellence networks, franchises, IA&R and all geographies, including Oncology BU. 7. Maintain external focus by interacting and influencing industry working groups and organizations 8. Communicate with IIS LT and ensure that initiatives’ objectives and priorities are in line with IIS strategy 9. Lead IIS hiring efforts in the area of Statistical Programming
Desired Skills & Experience
BA/BSc/MSc or equivalent experience in mathematics, statistics, computer science, or health sciences/related field. Fluent English required (oral & written) • At least 10 years relevant experience (or equivalent breadth of Pharmaceutical experience) including several years in a functional lead role • Excellent understanding of clinical development, quality and regulatory standards and policies relevant to Statistical Programming (e.g. GCP, ICH) • Expert knowledge of/experience with SAS and other relevant programming software. • Proven ability to effectively lead major non-clinical initiatives requiring programing expertise • Evidence of external focus with involvement in external industry activities • Very strong skills in leading operations and innovation • Excellent communication, collaboration and negotiation skills.
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