Data Analyst, CPSS (Clinical Pharmacology & Safety Sciences)

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details
Position Summary
The Data Analyst in Data Science Unit (DSU) of Clinical Pharmacology & Safety Sciences (CPSS) will be a primary resource for the development and validation of programs to support pharmacometric and clinical pharmacology analyses. He/she will assist in the development of specifications to ensure that PMx programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. He/she must demonstrate, at a minimum, an ability to comprehensively integrate statistical concepts with SAS/R Programming in an efficient and effective manner.
Principal Responsibilities
  • Apply computer science and information technology methods to provide the technical components that support analysis, reporting, decision-making process, regulatory submissions, commercialization and scientific utilization data for Alexion products.
  • Support development and/or validation of programs that generate tables, listings, figures/graphs using Alexion specifications.
  • Produce and maintain the technical database standards and Programming Specification documents
  • Contribute technical consulting on data (SDTM and PKPD) expertise to external partners in relation to the specification and delivery of the pharmacometric databases by these partners.
  • Support the regulatory submissions including specification and delivery of overview pharmacometric databases, outputs and response to regulatory questions under guidance
  • Manage external vendors and contract
  • Provide project progress updates of programming activities.
  • Identify opportunities to improve the methodology and provide practical solutions for problems
  • Contribute to the development of best practice to improve quality, efficiency and effectiveness
  • Any other activities as required.
Qualifications
Essential
  • Extensive SAS/R programming experience
  • Knowledge of technical and regulatory requirements related to the role
  • Knowledge of SDTM/ADaM and CDISC standard
  • Knowledge of PK, PKPD and NONMEM datasets preparations
  • Good communication skills
  • Collaboration with other functions such as pharmacometrics and statistics teams is required
  • Ability to apply programming expertise to problem solving and quality focus
  • Provide independent QC
  • A clear demonstration of behaviours of
    • Truth seeking rather than success seeking
    • Agile responsiveness to scientific data
Desirable
  • Varied programming languages (SAS, R, Python)
  • Minimum of 2 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Organization .
  • Proven ability to:
    • Develop and validate programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
    • Independently and collaboratively resolve problems
    • Clearly communicate processes and standards with management and team members
  • Minimal knowledge and understanding of:
    • SDTM and ADaM principals
    • Relational Databases.
    • Good Clinical Practice principals.
    • Good Programming Practice principals.
Education
  • BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.

Current Openings: 0

Our mission is to transform the lives of people living with rare diseases and devastating conditions through the development and delivery of innovative medicines, as well as through supportive technologies and healthcare services. By continuing to deepen our understanding of rare disease, which began with our pioneering work in complement biology, we are able to innovate and evolve into new areas where there is great unmet need and opportunity to help patients and families fully live their best lives. Our culture is rooted in integrity, inclusiveness, and our dedication to joining and supporting the communities in which we live and work. We invest in and value people who believe in the importance of our purpose and understand what it takes to deliver on it. Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world. At Alexion, our passion drives us to continuously innovate and create meaningful value in all we do. In doing so, we change lives for the better – ours, people living with rare diseases, and the communities we serve. Every day. Community Guidelines: https://bit.ly/39x9gqy
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