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Principal Statistical Programmer, Late Stage Development-Vaccines

Merck


Location:
Upper Gwynedd, PA
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
STA000857
Merck
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Job Details

Job Title: Principal Statistical Programmer, Late Stage Development-Vaccines  - STA000857

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. 

 

Responsibilities:

 

This position focuses on leading multiple statistical programming late development projects in the Vaccines therapeutic area, mentoring new programmers on submission tasks, and developing strategic solutions to the direct benefit of project teams and the Biostatistics organization.

 

The position is a key collaborator with internal and external stakeholders including Data Management, Statistics, Clinical Research and Regulatory organizations.

 

Primary Activities:

  • Address operational challenges that require strategic solutions, resulting in improved CSR and filing completion timelines worldwide
  • Lead Vaccines submissions, address US/ex-US agency questions and mentor other programmers across Vaccines therapeutic area.  
  • Facilitate global adoption of TA standards and programming best practices
  • Contribute to defining solutions for bringing external studies in-house to meet submission timelines
  • Mentor other programmers on life cycle of drug development in Vaccines area
  • Lead and actively contribute to departmental strategic initiative project teams
  • Contribute/Participate on external committees (e.g. ADAM, PhUSE, CDSIC, etc.) to align operational requirements with industry standards


Qualifications

Education:

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 12 years SAS programming experience in a clinical trial environment
  • MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum 10 years SAS programming experience in a clinical trial environment

Required Experience:

 

Department Specific Experience:

  • Excellent interpersonal skills and ability to negotiate and collaborate effectively
  • Excellent written, oral, and presentation skills
  • Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
  • Excellent project management skills; leadership across multiple and complex programs;  determines approach and ensures consistency and directs effort others; ability to engage key stakeholders

 Position Specific Experience: 

  • Expertise in SAS and clinical trial programming
  • Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
  • US and/or worldwide regulatory application submission experience at the leadership level including the development of electronic submission deliverables
  • Designs and develops complex programming algorithms
  • Familiarity with statistical analysis methods, terminology and concepts
  • Familiarity with clinical data management concepts
  • Experience in CDISC and ADaM standards
  • Demonstrated success in the assurance of deliverable quality and process compliance
  • Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
  • Ability to anticipate stakeholder requirements
  • Ability and interest to work across cultures and geographies

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 1

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