Group Lead, Biostatistics Oncology

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Basic Job Info

 
Company
 
Location
US-MA-Billerica
 
Job Type
 
Begin Date
11/13/2017
 
End Date
12/12/2017
 
Base Pay
N/A
 
Employment Type
Full-Time
 
Manages Others
False
 
Travel Required
None
 
Relocation Covered
False

Job Description

A career with EMD Serono is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.

Your Role: The position will lead a group of biostatisticians with respect to statistical strategy, statistical deliverables, statistical processes, and professional development. The Lead will provide statistical leadership for clinical development projects throughout the whole drug development life cycle. The Lead will be part of a department that plays a key role in the success of drug development at EMD Serono. In support to the group head, provide resource forecasts and ensure that all functional activities are performed to meet the defined timelines and quality specifications and per the Company strategy. As an expert in statistics, the person will be responsible to consider, evaluate and propose the optimal analysis methodology and data presentation techniques.

  • Translate problems into mathematical forms and use state-of-the-art modelling techniques to provide solutions
  • Direct and ensure the accuracy and timeliness of the vendor’s output and anticipate and communicate study level resource and quality issues that may impact deliverables or timelines and propose and implement solutions
  • Support the development and implementation of departmental standards and process improvements to maximize global data integration and interpretability. In addition, directly responsible for the statistical integrity, adequacy and accuracy of the clinical studies within the project
  • Represent the Biostatistics department in all interactions linked to the project that will take place with the Health Authority

Who you are

  • BS degree with a minimum of 10 years or MS degree with a minimum of 5 years or PhD with a minimum of 3 years' in clinical trials in the Pharmaceutical, Biotech industry or CRO environment is required.
  • Advance degree strongly preferred
  • Experience in design and analysis of clinical programs and studies, with strong knowledge in study designs used within Oncology is also required
  • Demonstrated project management skills is strongly preferred
  • Demonstrated experience with statistical packages such as SAS and R is required
  • Excellent communication and collaboration skills in English with ability to communicate clearly and effectively in written reports, data presentations and meetings is also required
  • Previous experience within Oncology will be helpful to progress rapidly in this position and to ensure that you successfully operate as a leading Statistician
  • Strong communication and influencing skills and great adaptability, interacting with the global project team, leveraging internal and external resources to achieve high quality, timely and cost-effective study deliverables are required
  • Must have a strategic approach towards drug development extending beyond the statistical aspects
  • In depth knowledge of regulatory guidelines in pharmaceutical research

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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

Job Requirements

 

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