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A career with EMD Serono 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
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 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 proper studies statistical activities; ensuring statistical analyses and adequate objective interpretation together with the results reporting & publications.
You will be able to
- Provide end-to-end cutting-edge statistical leadership without supervision for informative decision making to optimize the probability of success of new product development in rare disease or Neurology indications from the set-up of the integrated development plan to the delivery of all studies statistical analyses and objective data interpretation to reach full broad scope (Clinical, Safety, Regulatory, Epidemiology, HTA) of marketing authorization, reimbursement, and maintenance of product of value for patients:
- Provide statistical leadership without supervision in setting-up integrated development plan from the first time in man with decision criteria for stage-gate decision making
- Provide statistical leadership in the development of the different human research study designs and take accountability for the statistical matters
- Ensure that the planning and management of outsourced statistical deliverables (including 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 subjects’ studies, integrated safety summaries, and integrated efficacy summaries.
- When required, perform statistical analyses of study data
- Validate analysis results
- Ensure objective results interpretation and internal communication for studies or integrated summaries in support of informative decision making
- Ensure preparation of data package for file submission to health authorities. 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 discipline.
- At least 10 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
- Experience in the Pharmaceutical/Biotechnology industry in clinical development
- 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 ….)
- Aptitude 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!
Our Benefits - https://www.emdgroup.com/en/careers/benefits.html
Curious? Apply and find more information at https://jobs.vibrantm.com
If you are a resident of a Connecticut, Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.