A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
Provide statistical contribution to optimize probability of success of new products development, in at least one indication; the CRO oversight in delivering proper studies statistical activities; ensuring statistical analyses adequate objective interpretation together with the results reporting & publication(s), with management support, defend statistical design and results interpretation towards Health Authorities and Key External Experts.
Ensure that all functional activities supporting are performed to meet the defined timelines and quality specifications.
Provide statistical leadership for informative decision making to optimize probability of success of new product development in at least one indication to the delivery of all studies statistical analyses and objective data interpretation to reach usual scope (Clinical, Safety, Regulatory) of marketing authorization and maintenance of product of value for patients:
- 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 (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, integrated safety summaries, and integrated efficacy summaries.
- 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 line management supervision. Produce responses to regulatory agency requests
Who you are:
- PhD with 5 plus years of experience in the Pharmaceutical/Biotechnology industry in clinical development strongly preferred
- Minimum requirement:Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD
- Experience supporting global regulatory submissions is required. Knowledge of CDISC submission and integrated safety and efficacy summary
- Experience of project management as global statistical leader, preferably exposed to a multi-cultural environment.
- Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions.
- Excellent knowledge of ICH/GCP and other relevant regulations
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
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.