Director, Principal Statistician

Bayer•Hanover Township, NJ

17h

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Director, Principal Statistician The Director, Principal Statistician is a specialist in areas of statistical methodology relevant for the represented Statistics Sub-Cluster and/or in therapeutic area specific statistical methods. Preference for individuals with extensive Oncology late‑phase development experience and Health Authority/submission interaction expertise. The Principal Statistician builds and leads teams of statisticians and representatives from other functions and ensures the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management of Bayer products according to applicable global and regional standards, procedures and regulatory guidelines.

Requirements

PhD or MS in Biostatistics, Statistics or Mathematics;
Experience in leading teams of statisticians and/or representatives from other functions;
Extensive experience with Oncology drug development;
Embrace and role model the VACC (Visionary/Architect/Catalyst/Coach) behaviors in leadership, as well as mentoring/coaching capabilities across diverse cultural environments, in a DSO (Dynamic Shared Ownership) environment
High level of expertise in multiple fields relevant for his/her statistics sub-function;
Demonstrated excellent interpersonal, leadership and communication skills and ability to work both, independently and collaboratively with internal and external visibility;
Good knowledge of statistical programming languages (including SAS and/ or R).

Nice To Haves

At least eight years of experience as statistician;
A significant number of years in Oncology drug development as statistician, late-phase and submission experience with Health Authority interactions, with significant time spent in the Pharma, Biotech, or similar sector.

Responsibilities

Takes the statistical lead for an indication, compound and/or therapeutic area (such as Oncology);
Leads cross-functional virtual teams;
Drives the development and evolution of project, therapeutic area, and global standards;
Provides statistical and methodological consultation on special statistical methodology or on complex statistical, scientific and regulatory issues and mentors other statisticians and/or statistical analysts;
Represents the Statistics Sub-Cluster with respect to statistical aspects of clinical development programs and products to internal and external stakeholders. These include regulatory agencies, collaborations/business partners, KOLs, etc. Keeps abreast of regulatory and methodological issues, anticipates new needs in the area of responsibility and ensures development of innovative solutions;
Influences decision making processes during drug development and/or life-cycle management by use of appropriate statistical methodology (e.g. simulations, meta-analyses or modeling approaches);
Drives development and implementation of innovative statistical methodology;
Coordinates work with academic exports on themes related to the field of responsibility;
Applies Statistics and statistical methodology as an integral part of drug development and life-cycle management impacting the planning, design, analysis and reporting of clinical studies, projects and programs in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance;
Contributes to drug research, the development of new drugs, the approval of new drugs by health and reimbursement authorities, and the life-cycle management of marketed drugs according to the major tasks and responsibilities of the position
Is both internally and externally visible and works with (academic) experts to develop and implement innovative statistical methods that facilitate quantitative risk management decisions.