Biostatistician, Late Development Statistics

Job Description

Position Details:

Responsibilities:  

• Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.    

• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and our Company's Research Laboratories Scientists in analyzing clinical trials, and in coordinating other statistical activities for clinical drug/vaccine projects under supervision. 

• The incumbent may initially work in a specific disease therapeutic area. 

 

Primary activities: 

• Shadowing senior statisticians, serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.  

• Under supervision of senior statisticians, participates in study design; performs sample size calculations and simulations to support protocol development. 

• Under supervision develops statistical analysis plans and determines appropriate statistical methodology for data analysis.  

• Participates in database design meetings and reviews relevant study documents including CRF, Data Validation Plan, and Medical Monitoring plan to ensure that the data evaluated are in high quality and satisfy analysis requirements.  

• Collaborates with the statistical programming staff to provide definitions, documentations, and reviews derived variables needed for planned analysis; ensures 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.  Reviews study results to ensure all the deliveries in high quality.  

• Under supervision of senior statisticians, prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.  

• Involved in research activities for innovative statistical methods and applications in clinical trial development 

Education & Skills:

Education and Minimum Requirement:

• Master’s degree or equivalent in statistics/biostatistics or related discipline.   

 

Required Skills and Experience:  

• Knowledge of statistical analysis methodologies and experimental design.   

• Familiar with statistical and data processing software e.g. SAS and/or R.   

• Good oral and written communication skills. Able to work effectively with personnel with different functional background.    

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

BARDS2020

#eligibleforERP

Required Skills:

Biostatistics, Clinical Decision Making, Clinical Trials, Clinical Trials Analysis, Communication, Data Management, Data Science, Documentations, Numerical Analysis, Protocol Development, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Analysis, Statistical Programming

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$96,200.00 - $151,400.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/22/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.