Description:Description\: To fulfill the role of a Therapeutic Area Statistician participate in therapeutic areas Metabolism or Oncology and to serve as a Project Statistician for a high-profile project. To pursue statistical methodological research. To ensure quality and consistency of statistical contribution to clinical drug development on. Act as an internal statistical consultant on critical statistical issues in clinical drug development and regulatory science. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities\:
Represent statistical expertise and institutional memory in clinical development in specific therapeutic areas to ensure that research programs and submissions are statistically rigorous and efficient. Communicate with external statistical experts and project and trial statisticians with respect to appropriate trial design, analytic techniques, rules for addressing statistical issues, analysis plans, and inferences from data. Review from a statistical viewpoint important protocols, clinical trial reports, regulatory submissions, and manuscripts for presentation or publication to ensure quality and consistency across projects and across trials within projects within the therapeutic areas of expertise. Represent BIPI as a statistical leader in a field of expertise at national/international conferences, meetings and organizations and chair sessions in international statistics meetings. Provide internal statistical review requested by Senior Management, e.g., in-depth evaluation for in-licensing potential of new drugs. Mentor statisticians on the technical track and train non statisticians (clinicians, e.g., via TMM and TCM training). Serve on Data Monitoring Committees. Perform the responsibilities of a Senior Principal Statistician for a high profile project. Requirements\: Ph.D. in statistics, biostatistics, or biometry; at least 10 years experience in pharmaceutical clinical trial experience, preferably in the pharmaceutical industry and/or Regulatory Authorities, previous submission experience as a Project Statistician Must be recognized and accepted globally within the company and by the BDC as a statistical expert Ability to work on international project teams in order to come to resolution on a project Ability to mentor, motivate, teach a scientific/technical staff Offer scientific insight to projects and potential in-licensed candidates Excellent interpersonal skills with the ability to interact effectively with people, internally and externally at all levels of the organization Must have exceptional oral and written presentation skills Record of publications (principal author) in methodological research. Extensive knowledge of scientific area of responsibility; ability to ask critical scientific questions and to critique devised hypotheses, trial designs and results interpretation Demonstrated ability to successfully plan and conduct a submission project, including interactions with regulatory authorities on statistical issues. Demonstrated ability in supervising scientific/technical work.Eligibility Requirements\: Must be legally authorized to work in the United States without restriction. Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or olderOur Culture\: Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.