Senior Principal Scientist, Biostatistics

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck in Rahway, NJ seeks a senior Biostatistician within BARDS to lead biostatistics in late-stage clinical development and support regulatory interactions. You will design trials, supervise statisticians, and drive methodological innovation in collaboration with cross-functional teams.

Applicants should have a PhD or equivalent with extensive experience, or a Master’s with substantial experience, plus strong SAS and R skills, and a publication track record.

Qualifications

• 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.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong leadership and project management skills.
• Solid knowledge of statistical and data processing software e.g. SAS and R.
• Knowledge of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Excellent oral and written communication and leadership in a team environment.
• Publications in peer reviewed statistical/medical journals.
• Ability to learn, be proactive and motivated, and consistently focus on details and execution.

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 other our Company 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, Contract Research Organization and external statistical consultants.
• 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 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.
• Mentuors 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

Skills

Biostatistics

Clinical Development

Data Management

Data Processing

Data Science

Project Management

Regulatory Requirements

Statistical Analysis

Statistical Methods

Statistical Programming

Leadership

Study Design

Written Communication

Education

PhD or equivalent in statistics/biostatistics or related discipline

Master’s degree in statistics/biostatistics or related discipline

Tools

SAS

R

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.

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.

Role 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 other our Company 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, Contract Research Organization and external statistical consultants.

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 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

Education And 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 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.

Required Skills

Biostatistics, Clinical Development, Data Management, Data Processing, Data Science, New Program Development, Project Management, Regulatory Requirements, Statistical Analysis, Statistical Methods, Statistical Programming, Strategic Thinking, Study Design, Teamwork, Written Communication

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.

Requirements

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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $210,400.00 - $331,100.00

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.

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

• 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.

Requisition ID

R423600