Mid-level industry position
A career with EMD Serono is an ongoing journey of discovery: our 57,000 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 leadership for informative decision making to optimize probability of success of new product development. This includes responsibility for the planning, analyzing and reporting process of clinical trials. With your expertise in statistics you will contribute to the development and review of statistical aspects of protocols and analysis plans as well as to statistical analyses and final reports. You will translate problems into mathematical forms and use state-of-the-art modeling techniques to provide solutions. Further, you will supervise CROs and give input to common technical dossiers for regulatory submissions. You will interact with clinical and project teams and provide statistical/technical advice for drug development.
- 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.
- 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 line management supervision. Produce responses to regulatory agency requests that maintain perspective and are within the appropriate context exhibiting sensitivity to issues raised.
- Act as Sr Statistical SME at Global Program Team level with limited supervision on any project and normal scope (Clinical/Safety, Regulatory)
- Provide statistical leadership in setting-up clinical development plan from first time in man with decision criteria for stage gate decision making
- Ensure outsourced statistical deliverables are meeting expectations as well as proper interpretation of study results for informative decision making with the GPT and Sr Management.
- Review and contribute to clinical and statistical sections of regulatory submission dossiers, and lead the statistical strategy for the submission dossiers with support of line management.
- Able to learn and apply state-of-the-art statistical methodology for its project
- Direct the statistical contribution for clinical publications.
- Recognized externally for statistical expertise, contributing to working group
- Support Business Development, without supervision: Assess current available data in light of available literature data; provide statistical expertise, with scenarios, in terms of compound development to registration.
Who you are:
- A Ph.D. or M.Sc. in Statistics, Biostatistics or related discipline
- Fluent in english
- 8+years’ experience in the Pharmaceutical/Biotechnology industry in clinical development
- 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
- Experience supporting global regulatory submissions is required.
- Knowledge of Biostatistics in related survival analysis methods
- Clinical Development experience in cancer
Location may be flexible including remote.
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.