Associate Principal Scientist Job

Associate Principal Scientist-BIO004720


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


This position is for a Statistician who will contribute to projects aimed at identifying, developing and validating biomarkers and platforms (including genetics and gene expression) to be used as drug development tools for Merck compounds. These projects may be identified from internal and external, early and late phase clinical trials.

Primary responsibilities will be to:

- Develop, coordinate, and provide statistical leadership and support for projects focused on molecular and other exploratory biomarkers.

- Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing data from clinical trials. Coordinate all statistical activities for ongoing clinical projects. Interact with Contract Research Organizations, as appropriate.

Primary activities:

- Serves as a statistical representative on cross-functional teams for the strategic planning and execution of product development

- Develops individual protocols and statistical analysis plans and independently determines appropriate statistical methodology for analysis.

- 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 presentations and written reports to effectively communicate clinical trial results to the project team, Merck Management, regulatory agencies, or individual investigators.

- Consults on biomarker aspects of the clinical development strategy to meet scientific and regulatory project goals.

- Is involved in 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.

- Participates in database design meetings as needed, to ensure that the data evaluated are in high quality and satisfy analysis requirements.

- Collaborates with statistical programming staff to ensure 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.

- Responds to queries relating to study design, analysis, and interpretation posed by 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.

- Conducts research activities for innovative statistical methods and applications in clinical trial development, especially related to the use of oncology and pharmacogenetic biomarkers.


Education Minimum Requirement:

- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant experience, or a Master’s degree with a minimum of 6 years relevant experience.

Required Experience and Skills:

- Strong project management skills.

- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase I to II.

- Solid knowledge of statistical analysis methodologies and experimental design.

- Solid knowledge of statistical and data processing software e.g. SAS and/or R.

- Ability to work with large complex data sets.

- Strong oral and written communication skills.

- Ability to function effectively both independently and in a team environment.

- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial association with biomarkers.

- 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.

Preferred Experience and Skills:

- A specialization and relevant job experience in oncology and/or pharmacogenetics.

- An understanding of the biology of disease.

- An understanding of modern techniques for statistical and/or machine learning.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Biostatistics

Job Title:Assoc Prin. Scientist, Biostatistics

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Hazardous Materials: None

Company Trade Name:Merck