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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.

Date Posted

06-Feb-2024

Closing Date

30-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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Confirmed 5 hours ago. Posted 30+ days ago.

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