US-NJ, Principal Biostatistician, Oncology Clinical Development 233847BR-MZ
Principal Biostatistician, Oncology Clinical Development
East Hanover, NJ
Research & Development
Responsible for all statistical tasks on assigned oncology trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses using SAS, R, JMP, and/or PK, PK/PD analyses, exploratory biomarker including Next Generation Sequencing (NGS), RNA-seq data and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician. Explain statistical methodology like linear regression models, Bayesian logistic regression models, mixed effects model and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties 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 of status and issues related to the assigned trials. Develop statistical tools and R-packages using R Shiny and R Markdown to facilitate interactive discussions within and outside the team. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians (clinicians, programmers, drug regulatory affair specialists) and provide adequate statistical justifications for actions/decisions/statements as required. Support external scientific publications by data analysis and statistical graphics and visualization. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
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.
Candidate must have a PhD in Statistics or Biostatistics and 6 months experience in statistical modeling and programming using linear regression models, logistic regression, mixed effects model and R programming language. Must have experience in: statistical graphics and visualization; SAS, R, JMP, R Shiny, R Markdown and developing R-packages; providing statistical support for scientific publication; analysis of biomarker data including NGS , RNA-seq data. Consultation experience working with non-statisticians.
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.