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Principal Biostatistician, Clinical Safety Statistics

3 months ago

Lake Wales, Florida, United States Merck Full time

Job Description

The Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional group in our company's research laboratories. Since its establishment in 1938, this department has provided 85+ years of quantitative leadership in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development Division pre- and post-marketing development stages. Key responsibilities for the position

  • Serve as a statistical representative and core member in multiple Risk Management Safety Teams
  • Lead, coordinate, and provide biostatistical support for related drug/vaccine projects in Clinical Safety Statistics
  • Lead the interaction with Safety Physicians, Clinical Monitors, Regulatory, Early/Late Development Statistics, Statistical Programming, Data Management, and our company's Research Laboratories Scientists in the planning and execution of ongoing safety evaluation across pre-marketing and post-marketing development stages
  • Lead the design, development and evaluation of processes and tools for product safety evaluation, including ongoing aggregate safety evaluation

Primary activities for the position:

  • Serve as statistical lead in the cross-functional safety teams for the strategic planning and scientific reasoning that facilitates safety and benefit-risk evaluations
  • Plan and execute on aggregate safety evaluations, including cumulative meta-analysis of safety, as applicable. May take a team leadership role to coordinate and ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements
  • Take a lead role in the design, development and application of safety evaluation methods (including visual analytics), process, standard and tools
  • Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) staff to ensure high quality safety-related regulatory deliverables for NDA submission and periodic risk-benefit evaluation
  • Proactively interact with regulatory agencies worldwide to engage on statistical issues associated with the aggregate review of safety.
  • May represent Clinical Safety Statistics on company initiatives
  • Prepare oral and written reports to effectively communicate results of safety evaluations to the project teams
  • Mentor and guide junior staff in functional activities. May provide project oversight of junior staff, as appropriate.

Education and Minimum Requirement:

  • PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or Masters with a minimum of 9 years relevant work experience.

Required Skills and Experience:

  • Solid knowledge of statistical analysis methodologies and experimental design, particularly in meta-analysis and Bayesian methodologies.
  • Strong project management skills.
  • Solid knowledge of statistical and data processing software e.g. SAS and/or R.
  • Thorough understanding of worldwide regulatory requirements and broad clinical trial expertise from phase I 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 safety evaluation
  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focused on details and execution.

Preferred Skills and Experience:

  • Publications in peer reviewed statistical/medical journals.
  • An understanding of biology of disease and drug discovery and development.

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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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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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/26/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/26/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R306241