Association for Clinical and Translational Science

Associate Principal Scientist, Biostatistics

Merck
Rahway, New Jersey, United States
5 days ago

Description


Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Responsibilities :
  • Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
  • Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other company Research Laboratories 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).
  • This position may serve as a statistical lead in project teams.
  • The incumbent may initially work in a specific disease area.


Primary activities :
  • Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
  • 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 data 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, company 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.
  • Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
  • Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
  • Involved in research activities for innovative statistical methods and applications in clinical trial development.
  • Mentors and guides junior staff in functional activities.


Education & Skills

Education and Minimum Requirement:
  • PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a Master's degree with a minimum of 6 years relevant work experience.


Required Skills and Experience :
  • Solid knowledge of statistical analysis methodologies and experimental design.
  • Working knowledge of statistical and data processing software e.g. SAS and/or R.
  • Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
  • Strong oral and written communication skills. Able to function effectively in a team environment.
  • Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.


Preferred Skills and Experience :
  • Publications in peer reviewed statistical/medical journals.
  • Solid project management skills. An understanding of biology of disease and drug discovery and development.


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.

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.

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.

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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:

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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:
Yes

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R142015


Job Information

  • Job ID: 59226841
  • Location:
    Rahway, New Jersey, United States
  • Position Title: Associate Principal Scientist, Biostatistics
  • Company Name: Merck
  • Job Function: Other
  • Job Type: Full-Time

About our Company We aspire to be the premier research-intensive biopharmaceutical company in the world. Innovation and scientific excellence are at the core of what we do in pursuit of our mission to save and improve lives. Together, we invent for a more hopeful future. Who we are Our company, Merck & Co., Inc., Kenilworth, New Jersey, USA (known as MSD outside of the U.S. and Canada), is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. For m...

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