Job Description

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:

• (i) 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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Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

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 if you need an accommodation during the application or hiring process.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully 
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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Relocation:

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