Talent@ Boehringer Ingelheim

About Boehringer Ingelheim

Join Boehringer Ingelheim and be part of a legacy where your growth is just as important as ours. A global, research-driven pharmaceutical company, we are one of the world’s top 20 leading pharmaceutical companies and have collaborated and innovated medicines in Human Pharma, Animal Health and Biopharmaceutical everywhere in the world for over 130 years. This is your chance to create ‘Value through Innovation’ with our internal and external partners to improve lives around the world, explore new scientific breakthroughs to stay at the forefront of our industry, and become a leader for future generations.

We continue to grow fast and are one of the top growing companies in the industry in China. Join us and be part of our continued journey to grow and achieve BI global Ambition 2025:

? No. 1 in Animal Health

? No. 1 in Biopharmaceutical Contract Manufacturing

? No. 1 in value share for our brands in One Human Pharma

As a leading company, Boehringer Ingelheim thrives on passion, innovation and independence, and offers fulfilling work and growing opportunities to highly dedicated people. Certified as Top Employer in China in the past 5 continuous years, we help our people grow towards their success through high quality career development programmes and opportunities to lead international projects to develop into a leader of tomorrow. At the end of the day, your growth is our growth and vice versa.

About Human Pharmaceutical Business

With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system.

Our innovative medicines include those for COPD, hypertension, stroke, atrial fibrillation-related stroke prevention, Parkinson’s disease, diabetes and non-small cell lung cancer. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients. This vision is supported by industry-leading levels of investment. This includes more than a hundred R&D pipeline projects, around 50% of early- to mid-stage pipeline anchored in external innovation (2016), and around 20% of net revenue invested in R&D (2016) at a global level. Meanwhile, as one of the Company’s strategic pillars in China, Research Beyond Borders (RBB) explores emerging science, indications and technologies to expand R&D opportunities in China, and even the entire Asia.

Job 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 team 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.

Qualifications

• 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.

Behaviours

• Accountabilities – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions
• Agility – Quickly act with an open mind to face internal and external transformation
• Intrapreneurship – Together with customers, come up with innovative ideas to respond to changing markets

Contact Us

If you think you can convince us that you are the right candidate we are looking for, apply now!

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