Demo

Director Biostatistics

Novartis
East Hanover, NJ Full Time
POSTED ON 4/6/2025
AVAILABLE BEFORE 5/13/2025
Summary

~Biostatistique ~Influence et stimule la stratégie/l’innovation statistique au niveau de l’expert avancé, en participant directement à la collaboration interfonctionnelle et à la prise de décision pour plusieurs programmes, dans de multiples domaines d’indications/thérapeutiques/maladies dans le cadre du développement clinique (pré/précoce/complet) et/ou des affaires médicales. Responsable de la direction et de l’intégration des contributions de différents scientifiques quantitatifs, ayant un impact sur le développement clinique, les interactions avec les autorités sanitaires. Représenter la fonction au sein des conseils décisionnels internes et externes, former et encadrer d’autres statisticiens, et fournir un leadership et des solutions stratégiques, techniques, opérationnels et scientifiques.

~CDS-Aide le chef de la CDS à établir les normes et la stratégie d’automatisation à l’échelle de Novartis. Gérer une ou plusieurs équipes mondiales responsables de l’exécution des normes de données / objectifs d’automatisation dans l’ensemble du DO. Responsable de s’assurer que les normes et technologies de données de qualité, évolutives et réutilisables (CDISC et réglementaires) sont déployées de manière transparente dans l’ensemble de GDO en étroite collaboration avec les pairs externes de l’industrie et les parties prenantes internes, offrant une orientation client exceptionnelle. Responsable de la planification et de la supervision des indicateurs clés de performance/métriques, des cadres, des politiques, des règles d’affaires et des processus pour le développement, la maintenance et le déploiement. Responsable de veiller à ce que Novartis réalise un retour sur investissement dans l’ensemble du paysage des normes et de l’automatisation.

About The Role

Key Responsibilities:

  • Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a program
  • Strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
  • Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans
  • Collaborate across functions to ensure timeliness and quality of statistical deliverables
  • Propose and implement innovative designs and methods to optimize drug development.
  • Represent all functions within Advance Quantitative Sciences (Biostatistics, Pharmacometrics, Statistical Programming) at the Global Program Team (GPT).
  • Plan, prioritize and oversee project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors.
  • Lead the review and implementation of health authority guidance.
  • Represent biostatistics in interacting with external experts (statistical, clinical, and technical).

Essential Requirements

  • MS (in Statistics or equivalent) with 12 years relevant work experience or PhD (in Statistics or equivalent) with 8 years relevant work experience.
  • Has advanced knowledge of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas.
  • Record of successful implementation of novel methods and/or innovative strategies in drug development
  • Extensive knowledge of drug development and HA guidelines
  • Strong understating of at least one disease area
  • Fluent English (oral and written)
  • Strong interpersonal and communication skills bridging scientific and business needs

Desirable Requirements

  • Proven people leadership ability and expert skills in building partnerships and collaborations.

Novartis Compensation And Benefit Summary

The pay range for this position at commencement of employment is expected to be between: $185,500 and $344,500/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll Receive

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

https://www.novartis.com/careers/benefits-rewards

Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call 1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call 1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary : $185,500 - $344,500

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