Associate Director, Biostatistician

Posted 18 Oct 2022

Billerica, Massachusetts - United States

Req Id 257073


A career with EMD Serono is an ongoing journey of discovery: our 60,300 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 the product strategy in Medical Affairs and statistical support to study designs and exploratory analyses needed for the life cycle management of product of value for the patient. You will provide the CRO oversight in delivering accurate 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 in Medical Affairs and take accountability for the statistical matters
  • Ensure that the planning and management of outsourced statistical results (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 subject’s studies, coordinated 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
  • When required, ensure health care providers understand new product differentiation and safety. Collaborate cross-functionally providing statistical expertise and designing and conducting studies to address health care provider’s clinical questions 

Who You Are:

Minimum Qualifications:

  • Ph.D. or Master in Statistics, Biostatistics or related field
  • At least 8+ years of experience in the Pharmaceutical/Biotechnology industry in clinical development 


Preferred Qualifications:

  • Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions including medical affairs
  • R and SAS practical and effective knowledge
  • Excellent knowledge of ICH and other relevant guidance documents (from ICH, FDA, EMEA, etc.), using them pro-actively to impact the performance or find alternative solutions
  • Ability to interact with statistical experts, key opinion leaders, HTA authorities, Health Care Providers
  • Ability to ensure efficient collaboration between the Biostatistics Department and the Contract Research Organizations, Vendors, External Partners, and Data Monitoring Committees



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!


If you would like to know more about what diversity, equity, and inclusion means to us, please visit


If you are a resident of 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.


As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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