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Senior Statistical Programmer, SDTM

Merck


Location:
Upper Gwynedd, PA
Date:
08/17/2017
2017-08-172017-09-16
Job Code:
STA000844
Merck
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Job Details

Job Title: Senior Statistical Programmer, SDTM  - STA000844

Description

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
  • Collaborate effectively with project team members 
  • Participation in industry teams and conferences on best practices
  • Membership on departmental strategic initiative project teams 



Qualifications

Education: 

  • Required:
    • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment
  • Preferred:
    • MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment

Required: 

  • US and/or worldwide drug or vaccine regulatory application submission experience including the development of CRT SDTM study data standard deliverables
  • Experience with study data standards CDISC (SDTM), Define.XML, SDRG, aCRF; knowledge of ADaM and ADRG considered a plus
  • Expertise in SAS and clinical trial programming
  • Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
  • Excellent communication and negotiation skills / excellent teamwork and collaboration;  
  • Excellent written, 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:

  • Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
  • Experience assuring consistency across protocols and projects
  • Strategic thinking - ability to turn strategy into tactical activities
  • Ability to anticipate stakeholder requirements
  • Ability and interest to work across cultures and geographies
  • Ability to complete statistical programming deliverables through the use of 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 Meta Data Repositories


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 an accommodation for the application process please email us at 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:

 

            

            



Job Statistical Programming

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 2

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