Principal Statistician- Oncology

Bayer   •  

Whippany, NJ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 38 days ago

Your tasks and responsibilities

The primary responsibilities of this role, Principal Statistician - Oncology, are to:

  • Take the statistical lead for Oncology Medical Affairs activities for specific indications and/or compounds within oncology, working closely with the compound and project statisticians on one or more projects and ensuring appropriate development supporting the respective indication within the department.
  • Provide statistical and methodological consultation on special statistical methodology or on complex statistical, scientific, regulatory and health technology assessment issues and mentors other statisticians and/or statistical analysts. Drives exploratory analyses on internal and external data bases;
  • Facilitate the overall organization and coordination of statisticalactivities on the level of the indications in addition to the projectsfor which the incumbent is responsible, also ensuring appropriateprioritization within Medical Writing and Statistics Oncologyorganization;
  • Assemble and leads cross-functional virtual teamsInfluences decision making processes during oncology drug development and life-cycle management by use of appropriate statistical methodology (e.g. simulations, meta-analyses or modeling approaches);
  • Keep abreast of regulatory and methodological issues, anticipates newneeds in the area of responsibility and ensures development ofinnovative solutions. Drives development and implementation ofinnovative statistical methodology. Coordinates work with academicexperts on themes related to the field of responsibility;
  • Drive the development and implementation of project, indication specific, and global standards;
  • Represent the function with respect to statistical aspects of oncology life-cycle management programs and products to internal and external stakeholders. These include regulatory agencies, reimbursement authorities, collaborations/business partners, KOLs, etc.

Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • PhD or MSc in Biostatistics, Statistics or Mathematics, or relatedField;

• Outstanding interpersonal, leadership and communication skills;

• Ability to work independently as well as collaboratively, asRequired;

• Excellent knowledge of statistical programming languages (includingSAS and R);

• Fluent English skills;

• At least six years as a statistician with significant time spend inpharma, biotech or similar sector;

• Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associateddocuments and regulations;

• Demonstrated leadership skills in leading teams of statisticiansand/or representatives from other functions;

• High level of expertise in multiple fields relevant for medicalaffairs within Oncology Development;

• High affinity to internal and external collaboration, includingcommitment towards external visibility.