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-trialAs 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. Principal Biostatistician Duties & Responsibilities:•Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required. Collaborate with members of Clinical Research and Marketing, Trial Clinical Monitor and trial teams incl. pharmacokineticist in planning clinical trials and protocols conforming to company and regulatory agency guidelines and/or marketing and publication strategies.•Act as Project Statistician for early projects, backup projects,or projects with established BI experience.•Support Project Statisticians of high profile international projects 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.•Analyze data from phase I to IV trials incl. responsibility for program validation. Perform exploratory analyses in collaboration with the Project Statistician.•Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management.•Prepare specifications for data analyses by outside vendors as required. Assure compliance with the specifications by reviewing the vendors' products.•Participate on assigned international teams to promote harmonization efforts for clinical drug development.•Support management in resource planning and tracking for assigned trials and projects.•Act as a team leader for a complex project or mega-trial who•Ensures team members adhere to the SOPs, guidelines and local working instructions.•Attends all the meetings related to the trial/project needing a statistical input (or send delegates) and send minutes to the team members•Assist the Head of programming and Head of statistics with the working of vendors, contractors in establishing procedures for programming and validating statistical analysis (writes the scope of work, prepare documents to be sent to the contract research organization (CRO). From a statistical perspective, is the primary contact for CROs (programming validation)•Acts as a Trial or Project Statistician (TSTAT or PSTAT) for the trial/project. In particular, develops report and programming specifications in a Trial Statistical Analysis Plan (TSAP) and update this document as often as needed.•Collaborate with the programming group and the data management group to submit very detailed timelines for the trial/project to clinicians. Meeting agreed upon timelines are essential to the success of the clinical trial/project team objectives•From a statistical perspective, is the primary contact for medical writing (or choose a designee)•Ensures that protocol objectives are met and project standards are maintained (also responsible to update the project statistical analysis plan when necessary•Ensures achievement of major statistical deliverables and milestones in coordination with other functions including Clinical Research, Safety, Statistical Programming, Data Management and Medical Writing•Provides and organizes statistical support for regulatory meetings, questions and submissions.•Informs management that hours allocated to TSTAT by the capacity algorithm should be updated (follow up the amount of hours entered in the time recording system and related to the trial/project)•Ensures efficient work within the team by setting priorities and avoiding overlaps between team members•Works directly and proactively with the Trial, Project or Substance team.• Assumes responsibility for the coordination of all relevant statistical activities for a Trial, Project or Substance.•Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status. Alerts management in case of resources issues, timelines problems or conflicts within the team•In collaboration with the statistical expert group member, maintain expertise in therapeutic area, by keeping abreast of new publications with the purpose of increasing the overall efficiency or effectiveness in the department.
•Ph.D. in statistics, biostatistics, or biometry; at least 3 years experience in pharmaceutical clinical trial experience, preferably in the pharmaceutical industry and/or Regulatory Authorities, or M.S. in the above mentioned areas with six years of similar experience.•Ability to interact with authorities on statistical issues at the trial level.•Thorough knowledge of statistical methodology, processing clinical trial information and the drug development process.•Ability to communicate statistical information to non-statisticians.•Ability to write publications (as joint author) in clinical trials.•Excellent oral and written communication skills.•Ability to manage project from a statistical perspective.•Demonstrated ability to design, conduct and analyze a complex trial•Evidence of strong teamwork in order to successfully work with a trial team and project level team members
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