Senior Scientists, Biostatistics

Employer
Merck
Location
North Wales, PA, US
Posted
April 12 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: BIO005123

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. We are looking for Senior Scientists, Biostatistics (multiple) for our North Wales, PA location to be responsible for providing biostatistical support for drug/vaccine projects in Late Development Statistics and interacting with Clinical, Regulatory, Statistical Programming, Data Management and other Scientists involved in the design and analysis of clinical trials. Specific activities include the following:
  • Serve as statistical representative in cross-functional teams.
  • Participate in clinical development planning as statistical representative to help ensure that individual protocols and data analysis plans include appropriate statistical methodology for data analysis.
  • Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of clinical trials, propose solutions and execute.
  • Develop individual statistical protocols and data analysis plans and determine appropriate statistical methodology for data analysis.
  • Participate in database design meetings to ensure that the data evaluated are of high quality and satisfy analysis requirements.
  • Collaborate with the statistical programming staff on analysis requirements, internal standard operating procedures, and external regulatory requirements.
  • Evaluate appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
  • Analyze data and interpret results from clinical trials to meet objectives of the study protocol.  Apply and implement basic and complex techniques to these analyses.
  • Prepare oral and written reports to effectively communicate to the project team, management, regulatory agencies, or individual investigators.
  • Provides responses to queries posed by clinical monitors, regulatory agencies, and/or investigators related to statistical protocols and data analysis.
  • Be responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
  • Participate with management as statistical representative in discussions concerning proposed or ongoing studies.
  • Be involved in research activities for innovative statistical methods and applications in clinical trial development.
  •  Qualifications

    Qualifications
    • Master’s degree in Statistics/Biostatistics or related discipline.
    • 3 years of experience with statistical analysis methodologies and experimental design, working with clinical trial data, and using SAS and/or R.
    • We will also accept a PhD and 1 year of experience in stated areas.
     Our employees are the key to our company’s success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  If you need an accommodation for the application process please email us at staffingaadar@merck.com.  Search Firm Representatives Please Read Carefully:  Merck is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. 

    Job: Biostatistics
    Other Locations:
    Employee Status: Regular
    Travel:
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck

    More searches like this