Sr Principal Biostatistician -Early Clinical Biostatistics

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POST DATE 8/17/2016
END DATE 10/26/2016

Novartis Oncology East Hanover, NJ

East Hanover, NJ
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Responsible for all statistical tasks on early phase (phase I and II) in multiple global Oncology clinical development programs. Provide statistical designs for studies, preparing and writing the statistical components/sections of protocols which meet project objectives, health authority guidelines and clinical trial methodology standards. Develop and implement statistical analysis plans using SAS and R. Provide guidance for clinical data collection to determine the safety, efficacy and marketability of investigational drug. Coordinate programming resources for reporting activities including exploratory analyses and additional analyses to support publications. Reviews study reports and documents. Participates in dose-escalation teleconferences with Investigators, and responds to questions from health authorities around the world. Responsible for statistical consultation during the running phase. Develop Bayesian logistical/multivariate regression model to find MTD (maximum tolerated dose) in single agent and combination studies using WinBUGS and R. Explore empirical Bayesian analysis approach in global phase I trials. Develop exposure-QTc analysis and explore exposure response analysis using linear mixed model. Develop survival analysis approaches such as Kaplan-Meier analysis for progression free survival and overall survival analysis. Develop EXNEX (exchangeable and non-exchangeable) model which is a mixed Bayesian Hierarchical Model for survival analysis in clinical trials with multiple strata using WinBUGS and R. Provide specifications and directions to the clinicians and statistical programmers. Track clinical trial/allocated project activities and milestones and provide statistical guidance quality of all B&SR deliverables for the assigned trials and project tasks. Participate in or lead non clinical activities such as methodology development; establish and maintain sound working relationships and effective communication within the Clinical Trial Team/International Clinical Team and the senior reporting team. Create and collate statistical section of clinical study reports, INDs (Investigational New Drug), NDAs (New Drug Application), and annual reports. br br b EEO Statement /b br 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. br