Senior Principal Scientist, Biostatistics (Hybrid)

Job Description

Position Description:

Senior Principal Scientist, 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.

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 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

Position Qualifications:

Education Minimum Requirement:

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

• 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.   

• Immunology experience desirable

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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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, 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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