Senior Principal / Associate Director Biostatistics

323704BR
USA

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.

In the Senior Principal / Associate Director Biostatistics role, you will influence and drive statistical strategy and innovation through cross-functional collaboration and decision-making for assigned studies/brands/medical units within US CDMA. You will demonstrate a high level of independence in support of complex clinical trials in phases III and IV by leading quantitative strategy through collaborations across the organization. You will represent the Biometrics function at internal and external decision boards, develop and mentor other biometricians, and provide strategic, technical, operational, and scientific leadership and solutions to the team.

What you’ll be doing:
• Lead strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, statistical deliverables) from multiple therapeutic areas. Perform these tasks with a high level of independence seeking peer input/review, as required.
• Initiate, drive and implement novel methods and innovations in study designs and data analysis. Contribute to planning and execution of exploratory analyses, innovative analyses, exploratory biomarker analyses, co-author publications, and statistical consultation.
• Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, statistical reviews and recommendations to Business Development & Licensing (BD&L), and other drug development activities, as required.
• Actively participate as a statistical expert with external review boards/ethics committees, external consultants, steering committees, and other external parties with oversight, as appropriate.
• Represent Biometrics on cross-functional teams for the assigned studies and projects. Establish and maintain sound working relationships and effective communication within the study teams and Biometrics team.
• Independent oversight and timeliness of all Biostatistics deliverables and ensure quality of these 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

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

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.
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PHARMA
US PHARMA
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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323704BR

Senior Principal / Associate Director Biostatistics

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