首席生物统计师

Merck
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A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

  • As Principal: Act as Statistical SME at Regional Program Team level with supervision on normal project with focused scope (i.e., Clinical/Safety, Regulatory):

  • Able to integrate regional and global development needs

  • Handle routine studies without supervision and demonstrating ability to bring innovation

  • Drive statistical input for concept sheet (e.g., study design; sample size estimation for the most efficient and practical design; patient randomization) and ensure oversight of CRO for its execution (i.e., protocol/CRF development, integrated analysis plan approval, quality oversight of deliveries,…) without supervision for standard studies.

  • Write comprehensive statistical methods sections for the clinical study report; critically review and co-author these reports ensuring the accuracy of the statistical interpretation.

  • Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation

  • With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context

  • Understand and follow all Global Biostatistics WIs/SOP and relevant Standards as well as any other relevant WIs/SOPs. Contribute to the development of data and reporting standards

  • With supervision, support business development activities: Assess current available data in light of literature, Provide statistical expertise, with scenarios, in terms of compound development to registration

Who you are:

Required professional experience and necessary training

  • Ph.D. or MS in Statistics, Biostatistics or related discipline

  • Comfortable in Business English

COOPERATION

Describes if communication is mainly focussed on internal or external contacts

Gives also an indication what is main content of communication, e.g. negotiations, presentations, information, etc.

  • Collaborate closely with trial team functions (GCO, GCDS, GCDC, GDS, GED ….)

  • CRO counterpart and colleagues within the function

  • Health Authorities, External Experts (e.g., key opinion leaders)

WORK EXPERIENCE

Necessary professional experience

  • 5-7 years' experience in the Pharmaceutical/Biotechnology industry in clinical development

  • At least three years’ experience in SAS or R programming

  • Understanding of ICH/GCP; Able to retrieve and understand other relevant regulations

JOB-SPECIFIC COMPETENCIES & SKILLS

Specifies personal skills and competencies required

  • Preferably some experience in the Pharmaceutical/Biotechnology industry in clinical development

  • SAS and R practical and effective knowledge

  • Ability to develop an understanding of relevant clinical therapeutic areas

  • Results driven

  • Collaborative (Principal: regional setting)

  • Act purposefully

  • Exhibit routine and complex problem solving skills

  • Able to learn and apply state-of-the-art statistical methodology

  • Able to communicate statistical concepts and results to non-statistical stakeholders (Principal: regional setting)

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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Beijing%2C%20CN%2C%20Beijing%2C%20China

Beijing, CN

Beijing , China