Director, Biostatistics " >Director, Biostatistics


Job Description

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 the Director of Biostatistics, you will play a critical leadership role and participate in developing and implementing the strategic plans for US Medical Units by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process.
You will lead complex clinical trials primarily in phases IIIb and IV by leading quantitative strategy through collaborations across the organization and lead the biometrics teams consisting of statistics, data management and programming personnel for design and implementation of Phase IIIb and IV clinical trials.

What you’ll be doing:
• As the statistical expert and thought leader, lead and provide strategic statistical input and influence for one or more drug programs (development plan, regulatory strategy, publication strategy) for multiple brands from multiple therapeutic areas. Perform these tasks with a high level of independence seeking peer input/review, as required.
• Initiate, drive and lead implementation of novel statistical methods and innovations in study designs and data analysis. Contribute to planning and execution of exploratory analyses, innovative analyses, exploratory biomarker analyses, lead and co-author publications, and serve as statistical advisor.
• Provide statistical advice and expertise to support regulatory submission activities and documents; attend meetings with and respond to FDA and other Health Authorities; serve as statistical advisor to Health Economics and Outcome Research group, Investigator-Initiated Research proposals, and research collaborations with Academic Research Organizations; provide statistical reviews and recommendations for Business Development & Licensing (BD&L), and for other drug development activities.
• Actively participate as a statistical expert with external review boards/ethics committees, external consultants, steering committees, and other external parties that need oversight, as appropriate.
• Represent Biometrics in cross-functional teams for the assigned brands and programs. Establish and maintain sound working relationships and effective communication within the brand teams.
• Provide independent oversight and ensure timeliness and quality of all statistics deliverables. Collaborate cross-functionally (e.g., with data management, statistical programming, medical writing, and CROs) to ensure timeliness and quality of statistical deliverables.
• Participate in CRO qualification and selection processes. Guide relevant CRO personnel regarding statistical methods and standards.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:
• PhD (in Statistics/Biostatistics) with 10+ years relevant work experience as a statistician in healthcare industry and in data analysis and modeling.
• Fluent in English (oral and written), strong interpersonal, presentation and communication skills.
• Demonstrated excellence in use of statistical software packages (e.g., R, SAS) and simulation methodology.
• May require up to 10% travel.

• Leadership in innovative statistics and quantitative analytics to influence project team decisions and support to achieve objectives. Strong track record in the development and evaluation of modern study design methodologies.
• Proven knowledge and expertise in statistics and its applications to clinical trials and observational studies. Depending on the assignment, may require proven expertise in exploratory biomarker analysis, applied Bayesian statistics, survival analysis and data exploration using machine learning techniques.
• Strong knowledge of drug development and Health Authority guidelines. Strong understanding of multiple therapeutic areas.
• Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates.

You’ll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well.

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:

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
East Hanover, NJ
Research & Development
Full Time
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Director, Biostatistics

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