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A career at our company is an ongoing journey of discovery: our 60,300 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.
The Associate Director Biostatistician provides statistical contribution to optimize the probability of success of new product development in at least one indication from the set-up of the clinical development plan to the delivery of all study's statistical analyses interpretation to reach scope Clinical, Safety, Regulatory) of marketing authorization and maintenance of product of value for patients. You will provide the CRO oversight in delivering accurate studies statistical activities; ensuring statistical analyses and adequate objective interpretation together with the results reporting & publications.
You will be able to
Provide statistical leadership in the development of the different human research study designs in rare disease or neurology disease and take accountability for the statistical matters
Ensure that the planning and management of outsourced statistical results (include statistical programming) are effectively performed and are conducted to the highest quality and in a timely manner.
When required, write and develop the statistical analysis plans for human subject's studies, coordinated safety summaries, and integrated efficacy summaries.
When required, perform statistical analyses of study data and validate analysis results
Ensure objective results interpretation and internal communication for studies or integrated summaries in support for informative decision making in consultation with line management
Ensure preparation of data package for file submission to health authorities with supervision. Produce responses to regulatory agency requests that maintain perspective and are within the appropriate context exhibiting sensitivity to issues raised
Who You Are:
- You have a Ph.D. or Master in Statistics, Biostatistics or related field
At least 5 years experience in the Pharmaceutical/Biotechnology industry in clinical development
Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions
R and SAS practical and effective knowledge
Excellent knowledge of ICH and other relevant guidance documents (from ICH, FDA, EMEA, etc.). Use them pro-actively to impact the performance or find alternative solutions
Experience supporting global regulatory submissions is required
Ability to interact with statistical experts, key opinion leaders, and regulatory agencies (FDA, EMA, PMDA ….)
Ability to ensure efficient collaboration between the Biostatistics Department and the Contract Research Organizations, Vendors, External Partners, and Data Monitoring Committees
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