Senior Principal Statistician

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within Merck’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

• Serves as a statistical lead in project teams.

• Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.

• Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other our company's Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

• Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.

The incumbent may initially work in a specific disease area.

Primary activities:

• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development

• Lead a team of statistical and/or programing staff assigned to a development project as needed

• Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.

• Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.

• Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.

• May lead a team of statisticians and 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 statistical techniques to these analyses.

• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our company's management, regulatory agencies, or individual investigators.

• Represent biostatistics in regulatory interactions including presentation at advisory committee meetings

• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.

• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

• Lead research activities for innovative statistical methods and applications in clinical trial development.

• Collaborates in publication of research results in areas of applications.

• Mentors and guides junior staff in functional activities.

• Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed

Education & Skills

Education and Minimum Requirement:

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.

Required Skills and Experience:

• Solid knowledge of statistical analysis methodologies and experimental design.

• Strong scientific leadership in design and analysis of clinical trials

• Strong project management skills.

• Solid knowledge of statistical and data processing software e.g. SAS and/or R.

• Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.

• Excellent oral and written communication skills and strong leadership in a team environment.

• Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.

• Publications in peer reviewed statistical/medical journals.

• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience:

• An understanding of biology of disease and drug discovery and development.

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., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

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Requisition ID:R226808