Senior Director Biostatistics Sandoz

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Organisation
Novartis
Location
Basel, Switzerland
Application Deadline
Reference
289065BR

200+ compounds in Novartis are supported by biostatisticians in 10+ sites around the globe. Biostatisticians transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. They influence decision-making in cross-functional international teams from early to late phase drug development.

As Senior Director Biostatistics, you will influence and drive statistical strategy/innovation at advanced expert-level directly taking part in cross-functional collaboration and decision making for multiple programs, across multiple indications/therapeutic/disease areas within (pre/early/full) clinical development and/or medical affairs. You will be responsible for leading and integrating input from different quantitative scientists, impacting clinical development, health authority interactions.

You will represent the Biostatistics and Pharmacometrics function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.

You may be an individual contributor. In this role, you may serve as: -Global Program Biostatistics Head for a large program with multiple indications or multiple programs -Global manager -Thought leader across multiple indications/therapeutic/disease areas.

Your responsibilities will include:

Study level:

  • Ensure expert level contribution to strategy to complex, critical studies across programs/indications

Project level:

  • Independently lead a large program with multiple indications or multiple programs. Accountable for strategic statistical input and influence
  • Independently drive and influence strategy on program development and Health Authority interaction and may play a prominent role representing biostatistics at HA Advisory

Committees and meetings

  • Promote and organize data exploration, synthesis of external data to address risks, trial quality, further understanding, and put results into a broader perspective
  • May be a core member of the Global Program Team representing Biostatistics and Pharmacometrics
  • Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans
  • Facilitate seamless transition of projects from early to late development
  • Effective partnership with other functions to ensure integrated quantitative input into projects
  • Propose and implement innovative designs and methods to optimize drug development
  • Plan, prioritize and track project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors

Disease Area / TA/Indication level:

  • As partner to senior clinical and scientific leadership, drive strategic statistical input to and excellence in drug development across two or more therapeutic or disease areas/indications

Franchise or Global Line Function level:

  • Present advances statistical methods to senior leaders that aid or improve drug development
  • Plan, prioritize and track activities and ensure efficient resource management within the franchise and effective partnership with vendors
  • Identify, lead and/or significantly contribute to complex global cross-functional initiatives requiring the coordination of a diversity of team members
  • Drive, steer and mentor others in developing strategic quantitative frameworks for clinical programs in close collaboration with (early) project teams and Management
  • Identify and lead next generation opportunity for infrastructure / process / scientific consulting improvement initiatives

Minimum requirements

What you’ll bring to the role:

  • MS (in Statistics or equivalent) with 14+ years relevant work experience or PhD (in Statistics or equivalent) with 10+ years relevant work experience
  • Highly effective in influencing and decision making by developing innovative options and use of quantitative statistics for highly complex projects. Is able to clearly recommend a course of action to senior leaders/stakeholders
  • Provides statistical direction for department through extensive knowledge of applying cutting edge statistical methods. Expert understanding of the drug development process
  • Record of successful implementation of novel methods and/or innovative strategies in drug development
  • Has significant experience in HA activities
  • In depth knowledge of multiple disease areas
  • Expert skills and leveraging and maximizing the contributions of diverse teams

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.


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