Senior Scientist, Biostatistics

Job Description

• Provide biostatistical support for drug/vaccine projects in early development clinical trials aimed at evaluating early safety and tolerability, proof of concept, and characterizing the clinical pharmacology of investigational compounds.
• Ensure that sound scientific principles and statistical methods are applied to designing and analyzing clinical studies in support of discovery/experimental medicine/clinical pharmacology clinical trials (and possibly worldwide regulatory submissions).
• Interact with Clinical, Regulatory, Statistical Programming, Data Management and other research division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• Conduct project work and applied research.
• Serve as statistical representative on cross-functional teams for the strategic planning and execution for product discovery and development.
• Develop individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
• Participate in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• Collaborate with the statistical programming staff, as needed, to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Analyze data and interprets results from clinical trials to meet objectives of the study protocol.
• Prepare oral and written reports to effectively communicate results of clinical studies to the project team, management, regulatory agencies, or individual investigators.
• Provide responses to queries relating to study design, analysis and interpretation posed by the scientist, clinical monitors, regulatory agencies and/or other investigators.
• Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Participate in research activities for innovative statistical methods and applications in clinical trials for drug development.

Education Minimum Requirements:

• Must have Master's degree in Statistics or Biostatistics and 3 years of experience with biostatistics; statistical analysis methodologies and experimental design; statistical and data processing software (SAS and/or R); and working with scientists on multidisciplinary teams.
• Employer will also accept PhD in Statistics or Biostatistics and expertise in the areas of biostatistics; statistical analysis methodologies and experimental design; statistical and data processing software (SAS and/or R); and working with scientists on multidisciplinary teams, as demonstrated through employment or internship.

• Telecommuting permitted.
• 40 hours per week-M-F: 9am-5pm.
• Must have proof of legal authority to work in the United States.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Telecommuting

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R246933