Associate Director Statistics
- East Hanover, NJ
Associate Director Statistics
Novartis Pharmacometrics is composed of 85 quantitative scientists across US and Basel sites who support more than 80 clinical development projects in 10 therapeutic areas. We are strategic partners with the clinical teams to provide quantitative strategy and analytical support for making much-needed drugs accessible to patients within the shortest possible timeframe. Quantitative scientists in Pharmacometrics collaborate with international cross-functional teams to develop models to characterize exposure-response relationship and disease progression, explore biomarkers, and inform diagnostics development. These models and analyses allow optimal decision making on key development questions such as dose selection, treatment options, patient selection and patient monitoring.
The successful candidate will drive the biomarker strategy for early and full development clinical programs in multiple indications or a disease area. They will be responsible for initiating, performing, and executing the biomarker strategy in those programs to inform drug development. They will set the strategy for addressing biomarker issues in early/late phase trials, regulatory submissions and directly influence drug development decisions with internal and external partners. The role requires that s/he has a strong track-record of scientific and collaborative leadership in projects and initiatives.
• Provide statistical, scientific and strategic input to support the execution of the integrated precision medicine biomarker strategies in drug development.
• Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and support of submissions. Initiate, drive and implement novel methods, innovative trial designs, and dose-finding strategies in alignment with the Lead Statistician.
• Independently lead interactions with external parties (eg: KOL's, HA's), with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
• Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials.
• Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required.
• Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics & Pharmacometrics teams.
EEO Statement 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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Position will be filled at level commensurate with experience.
PhD in bioinformatics, statistics, biostatistics or other quantitative discipline preferred with extensive experience in bioinformatics preferred.
• Associate Director - PhD with 6+ years' experience preferred, OR MS with 10+ years' experience preferred.
• Able to effectively manage a diverse and dynamic workload.
• Programming skills in R.
• Knowledge of scripting language such as Perl, Python, with expertise in big data, data visualization, and web-based applications is a plus.
• Strong knowledge and understanding of statistical methods such as design of experiments, meta-analysis, MCMC simulations, bagging/boosting, variable selection methods (eg: lasso, elastic net, random forest), mixed models analysis and time to event analysis.
• Familiarity with statistical and analytical methods for genetics and omics data analysis is a plus.
• Ability to leverage technical and scientific information from a variety of sources in order to effectively enable data analysis and the scientific interpretation of analysis results
• Working knowledge of high dimensional exploratory biomarker platforms (e.g. next generation sequencing, transcriptomic, proteomics, flow cytometry, etc.) is preferred.
• Good understanding of clinical study design principles and familiarity working with clinical data in a clinical trial setting are preferred.
• Ability to collaborate and communicate effectively with Precision Medicine scientists, clinicians, programming, regulatory and other functions within a matrix organization.
• Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations.
Position may work in East Hanover, NJ or Cambridge, MA.
Why consider Novartis?
799 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 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.
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