Senior Scientist, Biostatistics, Early Development Statistics

Job Description

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.

This position is for a statistician who will contribute to early development clinical trials aimed at identifying, developing and validating biomarkers and platforms that can be used to make early go/no go decisions for our company's compounds. This would include working directly and partnering with cross-functional discovery/development teams.

Responsibilities:

·       Provides biostatistical support for drug/vaccine projects in Early Clinical Development Statistics.

·       Ensures that sound scientific principles and statistical methods are applied to designing and analyzing clinical studies in support of discovery/experimental medicine/clinical pharmacology clinical trials (and possibly worldwide regulatory submissions).

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

·       Conducts project work and applied research, as needed.

Primary activities:

·       Serves as statistical representative on cross-functional teams for the strategic planning and execution for product discovery and development.

·       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, as needed, to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.

·       Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.

·       Prepares oral and written reports to effectively communicate results of clinical studies to the project team, management, regulatory agencies, or individual investigators.

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

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

·       Participates in research activities for innovative statistical methods and applications in clinical trials for drug development.

Education Minimum Requirement:

·       PhD or equivalent degree in statistics/biostatistics, or (ii) a Master's degree in statistics/biostatistics with a minimum of 3 years relevant experience.

Required Experience and Skills:

·       Solid knowledge of statistical analysis methodologies and experimental design.

·       Solid knowledge of statistical and data processing software e.g. SAS and/or R. Strong oral and written communication skills. Able to function effectively in a team environment.

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

·       Ability to collaborate with scientists and work on multi-discipline teams.

·       Demonstrate interest in statistical research activities and in application of novel methods for clinical trials.

Preferred Experience and Skills:

·       Strong project management and multi-tasking skills.

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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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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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