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.
Develops, coordinates, and provides biostatistical support for
related drug/vaccine projects under supervision in Early Clinical
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
May interact with Contract Research Organization (CRO) and
external statistical consultants.
- Conducts project work and applied research, as needed.
Serves as a statistical representative on cross-functional teams
for the strategic planning and execution for product discovery and
Develops individual protocols and data analysis plans and
determines appropriate statistical methodology for data
Participates in database design meetings to ensure that the data
collected are of high quality and satisfy analysis
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
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
Required Experience and Skills:
Solid knowledge of statistical analysis methodologies and
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
- 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
Publications in peer reviewed statistical/medical journals.
- Good understanding of worldwide regulatory requirements and
clinical trial expertise particularly in early stage clinical
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. Together we will continue
Inventing For Life, Impacting Lives while Inspiring Your Career
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
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can engage in a hiring process that exhibits their true
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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.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck
Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept
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