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Principal Scientist, Biostatistics

Company: Merck & Co., Inc.
Location: North Wales
Posted on: June 12, 2021

Job Description:

Job Description

This position is for a statistician who will contribute to early phase clinical pharmacology trials aimed at identifying suitable drug candidates for the late clinical development space and additionally provide statistical support for late stage clinical pharmacology trials needed to support the product label. This position will use biomarkers and other platforms to help inform early go/no go decisions for our Company's compounds.

Responsibilities:

  • Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Early Clinical Development Statistics.

  • Ensures that sound scientific principles and statistical methods are applied to designing and analyzing clinical studies in support of discovery and worldwide regulatory submissions.

  • Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

  • May interact with Contract Research Organization (CRO) and external statistical consultants.

  • Conducts project work and applied research, as needed.

Primary activities:

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

  • Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.

  • Participates in database design meetings to ensure that the data collected are of high quality and satisfy analysis requirements.

  • Collaborates with 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 for implementation of novel statistical methodology.

  • Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of non-clinical or clinical studies, proposes solutions and carries them out.

  • Prepares oral and written reports to effectively communicate results of clinical studies to project team, management, regulatory agencies, or individual investigators. This would include providing responses to queries relating to study design, analysis, and interpretation posed by the scientists, clinical monitors, regulatory agencies, and/or other investigators.

  • Active participant with management and other scientific personnel at our Company with outside regulatory agencies concerning proposed or ongoing studies.

  • Involved in research activities for innovative statistical methods and applications in clinical trial development or drug development.

Position Qualifications

Education Minimum Requirement:

  • (i) PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience , or (ii) a Master's degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant experience.

Required Experience and Skills:

  • Solid knowledge of statistical analysis methodologies and experimental design.

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

  • Strong oral and written communication skills. Able to function effectively in a team environment.

  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

  • Good understanding of worldwide regulatory requirements and all phases of drug/vaccine development.

  • Ability to collaborate with scientists and work on multi-discipline teams.

  • Demonstrate interest in statistical research activities and in application of novel methods for clinical trials.

Preferred Experience and Skills:

  • An understanding of clinical pharmacology concepts including drug-drug interaction studies, special population studies and selective proof of pharmacology and/or proof of concept studies (IB) research in patients is desired.

  • Strong project management and multi-tasking skills.

  • An understanding of biology of disease and drug discovery and development.

  • Publications in peer reviewed statistical/medical journals.

  • Good understanding of worldwide regulatory requirements and clinical trial expertise particularly in early stage clinical pharmacology studies.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

BARDS2020

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Work Week

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Keywords: Merck & Co., Inc., Philadelphia , Principal Scientist, Biostatistics, Other , North Wales, Pennsylvania

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