A career with EMD Serono is an ongoing journey of discovery: our 51,000 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.
As Senior Principal: you are the statistical subject matter expert at Global or Regional Program Team level with supervision on normal project with focused scope (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.
- For integrated safety and efficacy summaries for regulatory submissions, without direction, write statistical analysis plans and perform statistical analyses
- 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
- Contribute to the development of data and reporting standards
- Contribute to process improvement according to lean concepts and to data and reporting standards improvement
- With supervision, support business development activities: Assess current available data considering literature
- Provide statistical expertise, with scenarios, in terms of compound development to registration
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 multicultural environment.
- Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions.
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.