Principal Scientist, Biostatistics

MSD Malaysia

Rahway (NJ)

On-site

USD 190,800 - 300,300

Full time

14 days+

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Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid holidays

Vacation

Compassionate time

Sick days

Job summary

Merck seeks a principal scientist in biostatistics to lead biostatistical support for drug projects and coordinate statistical activities across clinical trials. The role entails collaboration with Medical, Regulatory, and Data teams to ensure robust study designs aligned with worldwide regulatory needs.

The candidate should have Ph.D. (preferred) or MS in Biostatistics/Statistics with substantial trial experience, and demonstrate leadership in statistical methodology and regulatory submissions,

Qualifications

Ph.D. (preferred) or MS in Biostatistics/Statistics.
MS: minimum 9 years relevant work experience.
Ph.D.: minimum 6 years relevant work experience.
Experience in design and analysis of clinical trials and regulatory filings.

Responsibilities

Provide biostatistical support for drug projects under management supervision.
Lead a team of statistical staff as needed.
Participate in late development planning to align with global regulatory and marketing needs.
Identify problems in trial design and analysis and implement solutions.
Develop protocols and data analysis plans with appropriate statistical methodology.

Skills

Biostatistics

Clinical Trials

Regulatory Compliance

Regulatory Requirements

Scientific Leadership

Data Management

Data Science

Numerical Analysis

Statistical Analysis

Computing Software

Education

Ph.D. in Biostatistics or Statistics

MS in Biostatistics or Statistics

Job description

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

This role involves interaction with Medical, Data Coordination, Statistical Programming, our Research & Development Division scientists, and Regulatory staff in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects. The scientist may lead a group of statistical or programming staff assigned to a development project as needed.

Responsibilities

Develop, coordinate, and provide biostatistical support for drug projects under the supervision of management.
Lead a team of staff assigned to the project as needed.
Participate in late clinical development planning (LDP) to ensure study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of clinical trials, propose solutions and carry them out.
Develop individual protocols and data analysis plans and independently determine appropriate statistical methodology for data analysis.
Participate in worksheet development and database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information, and satisfy analysis requirements.
Determine the statistical programming needs and organize programming activities to ensure all programs meet analysis requirements, internal SOPs, validation, and external regulatory requirements.
Evaluate the appropriateness of available software for planned analyses and ascertain needs for potential program development of novel statistical methodology.
Analyze data and interpret results from experiments to meet objectives of the study protocol.
Independently apply and implement basic and complex techniques to these analyses.
Prepare oral and written reports to effectively communicate results of clinical trials to the project team, company management, regulatory agencies, or investigators.
Provide responses to queries relating to study design, analysis, and interpretation posed by clinical monitors, regulatory agencies, or investigators.
Ensure the accuracy of Statistical Review Aids submitted to regulatory agencies.
Participate with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
Collaborate in publication of research results in areas of application.
Independently conduct research on statistical methodology, pursue solutions to various technical problems, adapt known methods and develop new methods.
Maintain technical skills and increase own knowledge of new methods or areas of application by reading journals and attending professional society meetings.
Present own research at meetings and seminars.
Communicate with statisticians outside the company concerning technical problems.
Participate in departmental activities including recruiting and training other statisticians, providing statistical training for non‑statistical groups, department research effort, and other committee work.

Education & Experience

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

With an MS, a minimum of 9 years relevant work experience.
With a Ph.D., a minimum of 6 years relevant work experience.

Preferred Experience & Skills

Scientific leadership in design and analysis of clinical trials.
Experience with regulatory filing for approval of drug/vaccine products; regulatory submission experience strongly preferred.
Prior experience with respiratory and immunology disease areas is desired.

Required Skills

Biostatistics
Clinical Trial Management
Clinical Trials
Clinical Trials Analysis
Computing Software
Data Management
Data Science
Numerical Analysis
Regulatory Compliance
Regulatory Requirements
Scientific Leadership
Scientific Modeling
Standard Operating Procedure (SOP)
Statistical Analysis

Salary and Benefits

The salary range for this role is $190,800.00 – $300,300.00. The employee’s position within this range will be based on factors such as education, qualifications, certifications, experience, skills, geographic location, government requirements, and organizational needs. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, and other health insurance for employee and family, retirement benefits including 401(k), paid holidays, vacation, compassionate time, and sick days. Additional benefits information can be found at https://jobs.merck.com/us/en/compensation-and-benefits.

Equal Opportunity Employment

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 EEOC Know Your Rights, EEOC GINA Supplement. 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.

Location

San Francisco Residents Only: Qualified applicants from San Francisco will be considered.

Los Angeles Residents Only: Applicants from Los Angeles are considered for employment in a manner consistent with applicable local laws.

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