Associate Director Biostatistician

Merck
Posted on

Type

Executive / senior industry position

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.

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.

Your Role:

The Associate Director Biostatistician provides statistical contribution to optimize 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 and objective data interpretation to reach usual 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 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

Who you are:

Minimum Qualifications:

  • You have a Ph.D. or Master in Statistics, Biostatistics or related discipline.
  • 8+ 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

Preferred Qualifications:

  • SAS and R practical and effective knowledge
  • Experience in the Pharmaceutical/Biotechnology industry in clinical development and in Life cycle management
  • Excellent knowledge of ICH/GCP and other relevant regulations
  • Experience of interaction with statistical experts, key opinion leaders, regulatory agencies
  • Aptitude to ensure efficient collaboration between the Biostatistics Department and the Contract Research Organizations, Vendors, External Partners and Data Monitoring Committees
  • Ability to manage multiple projects of varying complexity, juggle priorities and deliver on tight deadlines

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.

More Information

Posted on

Type

Executive / senior industry position

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Billerica, US

Billerica , United States