Sr. Scientist, Biostatistics

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.

Responsibilities:
  • Develops, coordinates, and provides biostatistical support for projects under supervision in Late Development Statistics.
  • Interacts with Clinical, Regulatory, Statistical Programming, Data Management and our other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug projects.


Primary activities:

  • Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
  • Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
  • Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
  • Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
  • Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
  • Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.
  • Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
  • Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
  • Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
  • Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
  • Is involved in research activities for innovative statistical methods and applications in clinical trial development


Position Qualifications:

Education Minimum Requirement:
  • PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master's degree with a minimum of 3 years relevant experience.


Required Experience and Skills:
  • Knowledge of statistical analysis methodologies and experimental design.
  • Working knowledge of statistical and data processing software e.g. SAS and/or R.
  • Good oral and written communication skills. Able to work effectively with personnel with different functional background.
  • Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.


Preferred Experience and Skills:
  • An understanding of biology of disease, clinical trials and drug development. Oncology experience would be preferred.


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:
No

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R127602