Senior Scientist, Statistical Programming - A&R Platforms and Systems
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within Merck’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
This position supports the centralized management of technology, platforms, inspections, and related process and training 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.
Development or maintenance SOPs, corresponding processes, documents, and training
Development and maintenance of training content, including videos.
Business System Ownership of platforms or applications and corresponding documents and training
Drive compliance initiatives, change management and communication.
Partnership in managing, prioritizing, and implementing portfolio projects.
Engagement with operational staff and partners globally
Lead and actively contribute to departmental strategic initiative project teams.
Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 5-8 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.
MS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 2-5 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.
Department Required Skills and Experience:
Effective interpersonal skills and ability to negotiate and collaborate effectively.
Effective written, oral, and presentation skills
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders.
Position Specific Required Skills and Experience:
Comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)
Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry.
Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data.
Demonstrated success in the assurance of deliverable quality and process compliance.
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 including partnering with statistical programming staff in AP and EU regions and offshore programming resources.
Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users.
SAS or R programming experience
** Preferred Skills and Experience:
Experience developing and maintaining process documents e.g., SOPs.
Experience developing and maintaining training content, including videos.
Experience in process assessment, improvement, and operational excellence
Experience developing and managing a project plan.
Experience as a BSO for Good Clinical Practices (GCP) systems
Experience with SDLC, ALM, SAS, R, Jira, Confluence, Agile, Digital SDLC
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.
Who we are …
We are known as Merck & Co., Inc., Rahway, 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.
Residents of Colorado
Click here to request this role’s pay range.
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.
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:
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.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:107 600,00 $ - 169 400,00 $
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State Acts
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.
Flexible Work Arrangements:Hybrid, Work Week
Shift:1st - Day
Valid Driving License: