Senior SDTM Statistical Programmer (Hybrid)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company'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.

The Senior Study Data Tabulation Model (SDTM) Statistical Programmer, provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and validation of study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.

The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards deliverables and providing tools and templates to assist delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with statistical programming, statistics, global data management and other project stakeholders.

Primary Responsibilities:

• Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.

• Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.

• Up-versioning activities to specific versions of SDTM.

• Partner effectively with project team members.

• Participation in industry teams and conferences on best practices.

• Membership on departmental strategic initiative project teams.

Education:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 5 years SAS programming experience in a clinical trial environment.

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 3 years SAS programming experience in a clinical trial environment.

Required Experience and Skills:

• 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).

• Accountable for tasks at project level; ability to partner with key stakeholders.

• US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.

• Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.

• Demonstrated success in the assurance of deliverable quality and process compliance.

• Excels in technical writing, able to convert complex ideas and information into simple readable form.

• Solid project management skills.

• Familiarity with clinical data management concepts.

• Strategic thinking - ability to turn strategy into tactical activities.

• Ability to anticipate stakeholder requirements.

Preferred Experience and Skills:

• Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC).

• Assuring consistency across protocols and projects.

• Ability and interest to work across cultures and geographies.

• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.

• Developing and managing a project plan using Microsoft Project or similar package.

• Active in professional societies.

• Process improvement.

• Knowledge of Meta Data Repositories.

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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

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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.

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Requisition ID:R204310