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Sr. Statistician

Description:   Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required.  Assure well-designed clinical trials.  Provide statistical expertise necessary to design, analyze, interpret and communicate the results of complex clinical trials.  Provide statistical input for publications on clinical trials.  Either support Project Statisticians on complex projects or act as a Project Statistician for early projects, backup projects, or projects with established BI experience.  Act as a team leader for a complex project or mega-trial   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: Perform duties of a Trial Statistician to support regular clinical trials within national or international development projects or for marketed products as required.  Collaborate with Trial Clinical Monitor and trial teams incl. pharmacokineticist in planning clinical protocols conforming to company and regulatory agency guidelines.         Support other Trial Statisticians in their responsibilities.  Support Project Statisticians in their responsibilities, especially in their statistical responsibilities in the planning and preparation of regulatory submissions and contribute to efforts on cross-trial planning and harmonization.          Plan valid, efficient and cost effective clinical trials, typically based on outlines provided by Project Statisticians.  Prepare Statistical Methodology sections for the protocols and the Trial Statistical Analysis Plans (TSAPs).  Support other Trial Statisticians in their responsibilities.           Analyze data from phase I to IV trials incl. responsibility for program validation.  Support other Trial Statisticians in their responsibilities.          Prepare accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications.  Support other Trial Statisticians in their responsibilities. Support other Trial Statisticians in their responsibilities.           Prepare specifications for data analyses by outside vendors as required.  Assure compliance with the specifications by reviewing the vendors' products.       Review and evaluate proposed case report forms for consistency with information needs for the protocol.        Review randomization to be used in the clinical trials.         Support management in resource planning and tracking for assigned trials and projects.       Requirements: M.S. in statistics, biostatistics, or biometry with three years of experience in: designing, conducting, analyzing and/or presenting routine trials/studies, and working with a team to apply statistical methodology to a research question Or a Ph.D. in statistics, biostatistics, or biometry (must have received Ph.D prior to start date with the Company) with graduate level course work, project, consulting or internship experience in: writing the statistics section a protocol or analyzing a clinical trial/case study, and working with a team to apply statistical methodology to a research question, and communicating basic statistical information to non-statisticians Publishing: at least one publication (as primary or joint author) in a statistical, mathematical or clinical journal Good oral and written communication skills.. Attention to Detail - Possess a strong quality orientation.  Ensure tasks are completed correctly and on time.   Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older 1811404
Salary Range: NA
Minimum Qualification
Less than 5 years

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