Associate Director, Biostatistician

Morristown, NJ, United States
Apr 16, 2018
Required Education
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, Associate Director, Biostatistician, are to:

  • Be responsible and accountable for managing independently and globally as the only Consumer Health (CH) biostatistician all development and in-licensing initiatives in the Sun Care and Foot Care area as well as all Pharmacokinetic / Pharmacodynamic and Bioequivalence activities in any of the of the Consumer Health business areas including the statistical strategy and specification of experimental design and analysis, study execution procedures, data collection requirements as well as the strategy and methods for study data analysis. Acts to improve development process and to move forward lessons learned;
  • Be responsible and accountable for the oversight of statistical analysis, as well as interpretation and presentation of study results. Ensure the validity of findings and statistical interpretation. Manage external statistical resources in application of statistical methods as needed;
  • Resolve statistical methodology issues. Be responsible and accountable for the statistical part of regulatory submissions, presentations or defenses;
  • Be responsible and accountable for the statistical assessment including writing of statistical assessment reports on potential in- licensing initiatives as well as new technologies and development opportunities;
  • Establish strategies to provide services to all Bayer Consumer Health centers of clinical research;
  • Collaborate with the Clinical Leaders, Medical representatives, leadership in Clinical Development Services, and Regulatory to ensure that there is a coordinated completion of study deliverables from a statistics standpoint;
  • Represent Bayer Consumer Health, in regulatory interactions pertaining statistical issues;
  • Be responsible for all statistical portions of Bayer Consumer Health research projects, such as data analysis plans, data analyses, and reports, as well as the inclusion of these statistical outputs in the production of complete regulatory documents.

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:

  • Advanced degree in statistics (Masters) as well as broad experience in pharmaceutical research, specifically exposure to the IND/NDA approval process and Phase I, II, III and IV clinical research and clinical report requirements is required;
  • Minimum of 7 years of directly related pharmaceutical (or relevant industry) statistics experience;
  • Expert in experimental design and analysis;
  • Must have demonstrated skills in planning and project management, and budget development, monitoring and maintenance within pre-specified boundaries;
  • Practical experience with health authority meetings, and a comprehensive knowledge of ICH guidelines;
  • Excellent human relations and communication (written and oral) skills are required in the primary business language of English;
  • Have an outstanding record of successfully managing business relationships;
  • Experience managing Clinical Researcg Organizations;
  • Solid working knowledge of statistical software packages (e.g., SAS, JMP) and spreadsheet packages (e.g., MS Excel, MS Access);
  • Positive track record of working on teams, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company;
  • Demonstrated statistical leadership on medical research projects involving exploration of large clinical trial databases, generation of research hypotheses, and publication and presentation of scientific information;
  • Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance.

Preferred Qualifications
  • PhD

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country: United States
Location: NJ-Morristown