The primary responsibilities of this role, Director Med Statistics, 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;
- Drive exploratory analyses on internal and external data bases;
- Facilitate the overall organization and coordination of statistical activities on the level of the indications in addition to the projects for which the incumbent is responsible, also ensuring appropriate prioritization within Medical Writing and Statistics Oncology organization;
- Assemble and lead cross-functional virtual teams;
- Influence 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 new needs in the area of responsibility and ensures development of innovative solutions;
- Drive development and implementation of innovative statistical methodology;
- Coordinate work with academic experts 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.;
- Provide the basis of government approval of each drug and be presented so as to conform to strict regulatory (e.g. FDA, EMA) standards, this entails the design and analysis of clinical trials and the writing of statistical reports to be submitted to authorities as a crucial part of our New Drug Application (NDA) for each product;
- Work with statistics and statistical methodology, they are integral parts of drug development and life-cycle management in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance;
- Contribute 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;
- Be internally and externally visible and work with (academic) experts to develop and implement innovative statistical methods that facilitate quantitative risk management decisions within our company.
- The preferred location for this role is Whippany, NJ, but residence based candidates in the Central and Eastern Time Zones (with travel) will be considered.
- Visa sponsorship may be offered for this role.
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:
- Master's Degree or PhD in Biostatistics, Statistics or Mathematics, or related field;
- At least 8 years of experience as a Statistician (or similar role) with significant time spent in Pharma, Biotech or similar sector;
- Outstanding interpersonal, leadership and communication skills;
- Ability to work independently as well as collaboratively;
- Excellent knowledge of statistical programming languages (including SAS and R);
- Thorough knowledge of the Pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations;
- Demonstrated leadership skills, including leading teams of Statisticians and/or Representatives from other functions;
- High level of expertise in multiple fields relevant to Medical Affairs within Oncology Development;
- High affinity to internal and external collaboration, including commitment towards external visibility.