Posted in Science 30+ days ago.
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Location: East Hanover, New Jersey
We reimagine medicine to improve and extend people’s lives. We use innovative science and technology to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Associate Director Biostatistics
The digital revolution is dynamically changing the roles and the responsibilities of a biostatistician in the pharmaceutical industry due to the diversity of data now being collected and used in clinical trials and determine which patients are most likely to have the most benefit from new innovative therapies. At Novartis, we have more than 20 years of data and the volume is growing from a diverse portfolio of diseases that needs to be further explored to deliver the best innovative medicines to patients who will receive the greatest benefit.
Come to an industry leader where you will influence and drive statistical strategy and innovation through cross-functional collaboration and decision making for assigned studies/brands/Medical Units within US Clinical Development and Medical Affairs. Demonstrate a high level of independence in support of complex clinical trials and observational studies by leading quantitative strategy through collaborations across the organization. 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 organization.
-Responsible for all statistical tasks on assigned clinical trials or observational studies, and perform these tasks with a high level of independence seeking peer input/review as required.
-Responsible for development of study protocol, statistical analysis plan, and reporting activities; initiate, drive and implement novel methods and innovations in study design and analysis.
-Contribute to planning and execution of innovative exploratory analyses for publications and pricing; perform exploratory biomarker analyses, and provide statistical consultation.
-Provide statistical expertise to support regulatory submission activities, meet and respond to Health Authorities, provide statistical reviews and recommendations to Business Development & Licensing (BD&L) group, and other drug development activities, as required.
-Lead interactions 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.
-Establish and maintain sound working relationships and effective communication within the study team and Biometrics team; collaborate cross-functionally to ensure timeliness and quality of statistical deliverables.
-Participate in CRO qualification and selection processes; guide relevant CRO personnel regarding Novartis standards and requirements.
-Responsible for strategic statistical input and influence into one or more projects.
-May serve as a member of one or more Medical Tactical Team (MTT) representing Biometrics;collaborate with medical, clinical operations, regulatory and other strategic functions to drive quantitative decision making in robust drug development plans.
-Collaborate with Global Development Operations group for smooth transition of projects from pre-submission to post-submission phase of development.
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital technology and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.