Sr. Scientist, Biostatistics Job

Employer
Merck
Location
Gwynedd, PA, US
Posted
October 11 2017
Discipline
Other
Organization Type
Pharma
Sr. Scientist, Biostatistics-BIO004966

Description

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

This position is for a Statistician who will contribute to early phase clinical trials aimed at identifying, developing and validating biomarkers and platforms (including genetics and gene expression) that can be used as drug development tools for Merck compounds.

- Develops, coordinates, and provides statistical leadership and support for projects in the early development clinical space, with particular focus on molecular biomarkers and other exploratory biomarkers.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for ongoing clinical projects. May interact with Contract Research Organizations.

Primary activities:

- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
- Involved in research activities for innovative statistical methods and applications in clinical trial development especially related to the use of oncology biomarkers.
- Consults on biomarker aspects of 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.
- Develops individual protocols and statistical analysis plans and independently determines appropriate statistical methodology for analysis.
- Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
- Collaborates with the 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, Merck Management, regulatory agencies, or individual investigators.
- 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.

Qualifications

Education:

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

Required:

- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial association with biomarkers.
- Must also 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:

- An understanding of the biology of disease.
- A specialization and relevant job experience in oncology
- Ability to work with large complex data sets.
- An understanding of modern techniques for statistical and/or machine learning
- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase I to II.
- Strong oral and written communication skills. Able to function effectively in a team environment.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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.

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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:Sr. 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

Company Trade Name:Merck

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