Principal Statistical Programmer

1 month ago


Mississauga, Canada AstraZeneca GmbH Full time

This is what you will do:

The Principal Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and ADaM specifications, as well Tables, Listings, and Figures (“TLFs”) for analysis of efficacy data. They will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. They will serve as a Programming Lead and represent Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams. The Principal Statistical Programmer will act as a mentor to all other Statistical Programmers. They must demonstrate, at a minimum, an expert ability to comprehensively integrate statistical concepts with SAS Programming in the most efficient and effective manner.

You will be responsible for:

  • Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
  • Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
  • Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs based on Protocol SAP.
  • Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.
  • Supervise/manage external vendors and contract programmers.
  • Oversee progress of programming activities.
  • Review, maintain, and approve protocol specific documents as necessary.
  • Provide guidance and mentoring to peer and junior-level Programmers.
  • Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
  • Contribute ideas and thoughts towards the optimization of standard operating procedures.

You will need to have:

  • Bachelor’s Degree (Minimum) or Master’s Degree (Preferred) in Biostatistics, Statistics or another related discipline.
  • Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
  • Proven track record to:
    • Develop and validate technical specifications and 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.
  • Expertise in using SAS/Base, SAS/Macro, SAS/STAT.
  • Knowledge of SAS/Graph, and SAS/SQL.
  • Knowledge of:
    • SDTM and ADaM.
    • Relational Databases.
    • Good Clinical Practices.
    • Good Programming Practices.
    • 21CFR Part 11 Standards.
    • Integrated Summary Safety/Efficacy Analyses.
    • Safety data and Coding Dictionaries (MedDRA and WHODD).
    • ICH eCTD format.
#J-18808-Ljbffr

  • Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...


  • Mississauga, Canada AstraZeneca GmbH Full time

    This is what you will do:The Director of Statistical Programming will be primarily responsible for leading all aspects of statistical programming activities for multiple clinical studies within multiple Therapeutic Areas, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. They must possess...


  • Mississauga, Canada AstraZeneca Full time

    Senior Statistical Programmer - Late R&IAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of...


  • Mississauga, Canada Bell Full time

    **Résumé**: Ce poste relève du gestionnaire principal, gestion des programmes. **Principales responsabilités**: - Définit et dirige le plan directeur/programme de transformation SAP pour les équipes Finances, Chaîne d’approvisionnement et RH. - Gère les aspects financiers, comme travailler avec les fournisseurs et les ressources internes pour...


  • Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...


  • Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...


  • Mississauga, Canada AstraZeneca Full time

    p>At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    Description At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees...


  • Mississauga, Canada AstraZeneca Full time

    **Job Description / Capsule** The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They present a delivery/department mindset and management skills to run and oversee one moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field they...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking, and innovation – ultimately providing employees with the opportunity to work across teams, functions, and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking, and innovation – ultimately providing employees with the opportunity to work across teams, functions, and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...


  • Mississauga, Canada Bell Full time

    En tant que plus grande équipe de haute technologie au Canada, les Services de réseaux et de technologies construisent les réseaux de fibre optique et 5G de pointe qui déterminent la façon dont les Canadiens communiquent entre eux et avec le reste du monde! Notre équipe est à l’avant plan du développement des produits et services novateurs de Bell...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    **Statistical Science Director - Late Vaccines & Immune Therapies**: Location: Gaithersburg or Waltham (US) or Mississauga (CA) **Competitive salary and benefits**: **Play a meaningful role in making our pipeline accessible to patients.** AstraZeneca is a global, **science-led, patient-focused biopharmaceutical company **that focuses on the discovery,...