Senior Statistical Programmer, SDTM

Date: May 30, 2019

Location: Upper Gwynedd, PA, US

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Requisition ID: STA001001

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


The Senior Statistical Programmer, SDTM, 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 Case Report Tabulation (SDTM) study data deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating and consulting 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 standard deliverables and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. 
The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.

Primary Activities:
• Supporting project teams in creating SDTM deliverables for A&R and submission
• Supporting project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise
• Up-versioning activities to specific versions of SDTM
• Develop SAS programs, standards macros to enhance the process 
• Collaborate effectively with project team members 
• Participation in industry teams and conferences on best practices
• Membership on departmental strategic initiative project teams 

Qualifications

Education Minimum Requirement: 
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering plus 5-9 years SAS programming experience in a clinical trial environment.

Required Experience and Skills: 
  • Experience with study data standards CDISC(SDTM), Define.xml, cSDRG, aCRF; Knowledge of ADaM and ADRG considered a plus.
  • Experience in SAS and clinical programming.\
  • Knowledge and experience in developing analysis and reporting deliverables for R&D projects(data, analysis, tables, graphics, listings)
  • Excellent communication and negotiation skills / excellent teamwork and collaboration;
  • Excellent written and oral, and presentation skills; effective technical writing, able to convert complex ideas and information into simple readable form
  • A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
  • Solid project management skills.
  • Demonstrated success in the assurance of deliverable quality and process compliance.
  • Familiarity with statistical and clinical data management concepts.  


Preferred Experience and Skills:
  • Strong working knowledge of reporting processes (SOP) and software development life-cycle (SDLC)
  • Experience assuring consistency across protocols and projects
  • Strategic thinking – ability to turn strategy into tactical activities
  • Ability and interest to work across cultures and geographies
  • Ability to complete statistical deliverables using global outsource partner programming staff
  • Experience developing and managing a project plan using Microsoft Project or Similar package
  • Active in industry forums and professional societies
  • Experience in process improvement
  • Knowledge of Metadata Repositories (MDR)


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Statistical Programming
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: no
Company Trade Name: Merck

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