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Associate Director Statistical Programing, SDTM

Merck


Location:
Upper Gwynedd, PA
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
STA000843
Merck
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Job Details

Job Title: Associate Director Statistical Programing, SDTM  - STA000843

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 Associate Director Statistical Programing, SDTM, leads the statistical programming activities for the creation of SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of multiple drug and vaccine clinical development projects to the direct benefit of clinical development project teams.
The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.
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.

Primary Activities:
  • Effective SDTM deliverable creation for Analysis and Reporting (A&R) and submission, utilizing global and TA transformation standards
  • Maintaining and managing a project plan including resource forecasting
  • Oversight of the activities of a programming team that includes outsource provider staff
  • Assurance of deliverable quality and process compliance 
  • Addressing operational challenges requiring strategic solutions for improved timeliness and quality of regulatory submissions 
  • Membership/Leadership in industry teams and conferences on best practices and departmental strategic initiative project teams 



Qualifications

Education:
  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus minimum of 9 years SAS programming experience in a clinical trial environment
  • MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment

Required: 
  • Experience leading large and/or complex statistical programming projects that include coordinating/directing the activities of a programming team with US and/or worldwide drug or vaccine regulatory application submission experience including the development of CRT SDTM study data standard deliverables
  • Superior knowledge of study data standards CDISC (SDTM), Define.XML, SDRG, aCRF; knowledge of ADaM and ADRG considered a plus
  • Expertise in SAS and clinical trial programming
  • Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders
  • Excellent written, oral, and presentation skills
  • Excels in technical writing, able to convert complex ideas and information into simple readable form
  • Excellent project management skills; leadership across multiple programs; determines approach and ensures consistency directing the effort of others; ability to engage key stakeholders
  • Demonstrated success in the assurance of deliverable quality and process compliance.
  • Familiarity with statistical and clinical data management concepts
Preferred:

  • Experience in process assessment, improvement and operational excellence methodologies
  • Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
  • Experience providing technical and/or programming guidance and mentoring to colleagues
  • Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
  • Ability to anticipate stakeholder requirements Deals well with change and seamlessly assimilates to new projects and stakeholders
  • Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D 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 
  • Experience developing and managing a project plan using Microsoft Project or similar package 
  • Active in industry forums and professional societies
  • Experience with 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.

 

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Job Statistical Programming

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 1

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