Senior Director, Biostatistics

Job Description

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:

• Supervises a group of statisticians in Late Development Statistics.

• Provides biostatistical and operational leadership to a team of statisticians in developing and coordinating statistical activities supporting drug/vaccine projects.

• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in long-range project planning, providing guidance to others in the statistical support for clinical drug/vaccine projects.

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

• This position may serve as a statistical lead in project teams.

The incumbent may initially work in the cardiovascular or metabolism disease areas.

Primary activities:

• Directs the scientific and technical development of statisticians. Encourages staff to conduct statistical research and publish/present scientific findings/methodologies. Mentors and guides junior staff in functional activities. Encourages staff to conduct statistical research and other non-project activities.

• Performs managerial, administrative duties including coaching, performance evaluation, expense report approval consistent with grant of authority

• Directs recruiting effort to hire qualified statisticians

• Directs biostatistical support required for assigned projects

• Serves as lead statistician in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions

• Lead a team of statisticians and the statistical programmers to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements

• Represent statistics in meetings with management in strategic planning of projects

• Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies

• Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory and marketing needs

• Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and submission documents to ensure accuracy of the statistical content

• Provides effective and efficient statistical oversight and ensures consistency of methodology

• Coordinates statistical project assignments and resource allocation with other managers

• Identifies needs for new statistical techniques

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:

• Prior supervisory and project management experiences are necessary.

• Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing software, e.g., SAS and/or R.

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

• Excellent oral and written communication skills.

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

Preferred Skills and Experience:

• Publications in peer reviewed statistical/medical journals.

• Involved in research activities for innovative statistical methods and applications in clinical trial 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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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R208303