Principal Statistical Programmer, RWE

2 weeks ago

United Kingdom SEC Life Sciences Full time

With over 100 years of heritage in the pharmaceutical sector, we are working with a boundary-pushing organisation who are dedicated to improving lives through innovative healthcare solutions. Their mission is to deliver new standards of care that enhance the quality of life globally.


The firm are involved in two core areas:

Cardiovascular Health: Protecting people from cardiovascular disease, the leading cause of death in Europe.

Oncology: Striving to become a global pharma innovator by creating novel therapies for cancer patients.


This is a position that can be worked from anywhere within Europe or Canada, but with very occasional visits to the firm's site in Germany.


Your Role as Manager Statistical Programming


Lead Statistical Programming Activities:

  • Overseeing the end-to-end delivery of statistical programming services for assigned studies.
  • Collaborating with CROs and other vendors to ensure high-quality deliverables are on time and within budget.
  • Reviewing SAPs and TFL shells from a programming perspective.
  • Developing and validating SAS programs to create SDTM and ADaM datasets and TFLs.
  • Ensuring timely and accurate completion of statistical programming deliverables.


Vendor Oversight:

  • Managing routine oversight of vendor delivery to ensure compliance with protocols, standards, and regulatory guidelines.
  • Contributing to the development of requests for proposals for CRO selection.
  • Participating in budget management and activities across project durations.
  • Providing advice during meetings or teleconferences with vendors.


Operational Excellence and Innovation:

  • Participating in global initiatives to improve process harmonization and efficiency.
  • Staying updated on industry best practices in statistical programming methodology.


Regulatory and Compliance:

  • Contributing to documents submitted to regulatory or pricing authorities.
  • Maintaining inspection readiness and preparing for potential audits linked to assigned studies.
  • Ensuring compliance with international regulations and guidelines.



Experience and Qualifications for the Manager Statistical Programming Role


Education and Experience:

  • Bachelor's degree in Statistics, Computer Science, Mathematics, or a related field.
  • Relevant experience in statistical programming within the pharmaceutical industry.


Technical Skills:

  • Proficiency in SAS programming.
  • Working knowledge of SDTM and ADaM datasets, TFLs, and related industry standards.
  • Familiarity with XML/PDFs, ARM, aCRFs, and Reviewers Guides.


Professional Skills:

  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to manage multiple projects and collaborate with various stakeholders.


Regulatory Knowledge:

  • Understanding of regulatory requirements and guidelines for statistical programming.
  • Experience with inspection readiness and audit preparation.



Apply today, or reach out directly for any questions relating to this position. For information on similar positions please feel free to connect.

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