Principal Scientist, Biostatistics

Job Description

Position Description

This position is for a principal scientist in biostatistics. The candidate should have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials. The knowledge must be sufficient to ensure that sound scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.

This position involves interaction with Medical, Data Coordination, Statistical Programming, Research Laboratories scientists and Regulatory staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development project as needed. More specifically,

• Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management. Lead a team of staff assigned to the project as needed. This includes the following activities:
  1. Is involved in late clinical development planning (LDP) to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
  2. 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.
  3. Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for data analysis.
  4. Participates in Worksheet development, database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.
  5. Determines the statistical programming needs and organizes the programming activities to ensure that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements.
  6. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
  7. Analyzes data and interprets results from experiments to meet objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.
  8. Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Management, regulatory agencies, or individual investigators.
  9. Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators.
  10. Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
  11. Participates with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

• Collaborates in publication of research results in areas of applications.

• Independently conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods and develops new methods.

• Maintains technical skills and increases own knowledge of new methods or areas of applications by reading journals and attending professional society meetings. Presents own research at meetings and seminars. Communicates with statisticians outside concerning technical problems.

• Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical groups, department research effort, and other committee works, etc., as needed.

Position Qualifications :

Education Minimum Requirement: Ph.D (preferred) or MS in Biostatistics or Statistics

Required Experience and Skills: With a MS, a minimum of 9 years relevant work experience; with a Ph.D., a minimum of 6 years relevant work experience.

Preferred Experience and Skills: Broader scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for approval of drug/vaccine products; Prior experiences with immunology clinical trials design, analysis and reporting strongly preferred

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US and Puerto Rico Residents Only:

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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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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 salary range for this role is

$187,000.00 - $294,400.00

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 employees 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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Biostatistics, Clinical Development, Clinical Immunology, Clinical Study Design, Clinical Testing, Clinical Trial Management Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Scientific Modeling, Standard Operating Procedure (SOP), Statistical Programming, Statistics, Waterfall Model

Preferred Skills:

Job Posting End Date:

08/8/2025

*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.