Senior Principal Biostatistician, Methodology Research

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, 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:

• Contributes expertise and creativity to the collective subject matter knowledge and aids in solving complex problems supporting statistical methodology in the pharmaceutical industry.

• Provides strategic scientific leadership, originates and develops new methodology ideas.

• Consults with clinical trial teams and other functional areas to implement advanced design and analysis.

• Publishes relevant statistical methodology in peer-reviewed journals and presents at professional meetings.

• Interacts with contractors on significant outsourcing projects.

• Collaborates on internal standards development, strategic initiatives and training.

• Maintains external relations and contributes to relevant professional activities/associations.

Primary activities:

• Independently identifies, anticipates and responds to technical and strategic problems arising in the design, conduct, and analysis of clinical trials; proposes solutions and carries them out or consults to enable others to implement.

• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. As needed, consults in development or co-develops software for advanced methods.

• Independently applies and implements advanced analytical methods to design and analysis of clinical trials.

• Prepares oral and written reports to effectively communicate results of advanced methods to project teams, strategic initiatives, our company's Management, or regulatory agencies.

• The Methodology should be documented and maintained to enable reproducible and well-documented implementation. Also coaches others to document and retain important methods for implementation.

• Represent biostatistics in regulatory interactions including presentation at advisory committee meetings when technical issues require.

• Provides responses to queries relating to advanced methodology posed by clinical researchers, regulatory agencies, and/or investigators.

• Guide research activities for innovative statistical methods and applications in clinical trial development and other relevant areas.

• Collaborates in publication of research results.

• Mentors and guides junior staff in research and functional activities.

• Participates in departmental activities including recruiting and training, as needed

Education & Skills

Education and Minimum Requirement:

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years of relevant work experience

Required Skills and Experience:

• Solid knowledge of statistical analysis methodologies and experimental design.

• Strong scientific leadership in the design and analysis of clinical trials and/or other areas of interest for pharmaceutical drug development.

• 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 I to V.

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

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

• Publications in peer-reviewed statistical/medical journals.

• Demonstrated ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience:

• Recognized as an expert in the quantitative sciences within the company and externally with a strong reputation within the biopharmaceutical sciences.

• Knowledge of statistical methods in emerging areas (e.g., machine learning, complex adaptive trial design, causal inference) as well as applications in related to other relevant areas (e.g., reimbursement, safety, real-world evidence, epidemiology).

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

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.

Residents of Colorado

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R151814