Description:

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.

 

This position supports the centralized management of technology, platforms and related process for the global Statistical Programming organization.  The individual supports the organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements and standards. 

 

Primary Activities:

  • Primary Activities:

  • Oversight of change management across multiple audiences
  • Maintenance of SAS tool used to generate departmental metrics
  •  
  • Creation and maintenance of Excel tools used to generate metrics
  • Business System Ownership of platforms or applications and corresponding documents and training
  • Development or maintenance standard operating procedures, corresponding processes, documents and training
  • Oversight of departmental compliance for processes, training, and technology
  • Engagement with operational staff and partners globally
  • Driving compliance initiatives
  • Leading and actively contributing to departmental strategic initiatives

 

Education Minimum Requirement:

 

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years in a clinical trial environment (Analysis & Reporting,  Information Technology, Data Management etc.) in the pharmaceutical industry, and 4-6 years SAS programming experience

 

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7  years in a clinical trial environment (Analysis & Reporting,  Information Technology, Data Management etc.) in the pharmaceutical industry, and 1-3 years SAS programming experience.

 

Department Required Skills and Experience:

  • Excellent interpersonal skills and ability to negotiate and collaborate effectively
  • Excellent written, oral, and presentation skills
  • Proven project management skills; leadership; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
  • Position Specific Required Skills and Experience:

  • SAS programming experience in a clinical trial environment
  • Experience testing systems and applications
  • Solid experience with documenting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life-cycle (SDLC)
  • Experience in change management
  • Knowledge in regulatory and compliance management
  • Excellent decision making skills and the ability to execute effectively on a plan
  • Demonstrated success in the assurance of deliverable quality and process compliance
  • Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data
  • Ability to anticipate stakeholder requirements; focus on customers; ability to listen to and address stakeholders’ needs and concerns
  • Ability and interest to work across cultures and geographies
  •  

** Preferred Skills and Experience:

 

  • Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users
  • Experience with developing process documents and training content
  • Experience as a business system owner (BSO), business analyst (BA) or SAS programmer
  • Understanding of Change Management
  • Experience in process assessment, improvement and operational excellence methodologies
  • Experience managing projects and generating metrics using Excel, MS Teams, Share Point, Power BI, R, JIRA or similar packages
  • Active in professional societies

 

 

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.

#eligibleforERP 
#BARDS2020 
#SPJOBS

VETJOBS

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

 

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.

 

 

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

Pay Transparency Nondiscrimination

 

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., 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.

About Merck:

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