Biostatisticians for direct hire positions with Novartis Oncology
Departments: Full development, Biomarker, or CDx (Companion Diagnostics). If interested, email linda.paradise@novartis.com
Location: East Hanover, NJ or Cambridge, MA
Support the Biostatistics Team by providing analysis and interpretation of study datasets, providing statistical consultation during all phases of a study. Develop program code for manipulation and analysis of study datasets, including graphics and tables for the presentation / reporting of clinical data using SAS and/or other statistical packages.
1. Develops statistical methods and programs, analyzes data, and writes statistical reports to achieve objectives within given timelines.
2. Designs, implements, and tests programs for statistical analysis of assigned studies. Develop tables and graphs for inclusion into statistical reports, safety reports, final study reports, presentation slides, and publications.
3. Supports the development and maintenance of the library of SAS (Base, STAT, Graph, ODS) and other statistical programs. Develops and maintains a repository of statistical literature.
4. Understands and proactively utilizes knowledge of pertinent local and/or international Regulatory Requirements, and may participate in or lead interactions with local Regulatory Agencies under the guidance of more experienced Biostatisticians.
5. Will attend working groups, conferences, and technical meetings.
6. Collaborates with other associates to facilitate knowledge exchange.
7. Assists in the preparation SOPs related to job function.
8. Works following external and internal guidelines (e.g. SOP’s, GxP, HSE, AW).
9. For the CDx position: Responsible for all statistical tasks on the CDx assigned project for ex. Design/plan analytical performance & bridging studies, regulatory interactions, reporting activities, & statistical consultations
Job requirements:
PhD in Statistics or Biostatistics
0-1 year experience for PhD or Post Doc
Oncology experience is preferred for ex. Thesis, industry internships, job experience
Knowledge of SAS and R required
For the CDx department: experience with design control (DFSS, DoE or RSM a plus
Advanced knowledge of English (oral and written)