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Job Details


Merck & Co, Inc

Senior STDM Statistical Programmer (Hybrid PA / NJ)

Science and Research

Research Programmer

No

North Wales, Pennsylvania, United States

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.

#EligibleforERP

BARDS2020

SPJOBS

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.

Residents of Colorado

Click here to request this role’s pay range.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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 Know Your Rights

EEOC GINA 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.

Under New York City 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:

$96,700.00 - $164,500.00

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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R204310