Senior Director, Biostatistics (Hybrid)
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’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.
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 company 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 a specific disease area.
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 insure 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
Involved in research activities for innovative statistical methods and applications in clinical trial development.
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.
Immunology and Respiratory therapeutic area experience preferred.
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.
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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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State 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:$175,440.00 - $276,200.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Flexible Work Arrangements:Hybrid
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