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Senior Statistical Programmer - Late R&I

2+ years
Not Disclosed
10 Oct. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Statistical Programmer
Location: Toronto, Canada

Join AstraZeneca: Innovate with Purpose

At AstraZeneca, we pride ourselves on fostering a collaborative culture that champions knowledge-sharing, ambitious thinking, and innovation. Our flexible working model allows employees to balance personal and professional commitments while ensuring strong teamwork through face-to-face interactions in our offices three days a week. Our head office and BlueSky Hub in downtown Toronto are designed to encourage collaboration, providing spaces for teams to strategize and connect on key projects.

Commitment to Sustainability

Our dedication to sustainability is at the heart of our culture. We understand that the health of people, the planet, and our business are interconnected. That’s why we’re taking ambitious actions to tackle some of the biggest challenges of our time, including climate change and healthcare access.

Your Role in Drug Development

Are you passionate about SAS programming and eager to impact all phases of drug development and regulatory interactions? Join AstraZeneca and apply your expertise to drive meaningful change in the healthcare landscape. As a global biopharmaceutical company, we focus on discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases.

About the Late R&I Biometrics Team

Our Late R&I Biometrics team is dedicated to developing innovative treatments for Respiratory and Immunology diseases. Here, you will join a diverse, global, and cross-functional team that prioritizes personal and professional development.

Main Duties and Responsibilities

In this role, you will utilize your statistical programming expertise to manage and generate evidence for our product portfolio through analysis and reporting of clinical trials and exploratory analyses.

What You'll Do:

  • Lead statistical programming deliverables for regulatory submissions, including datasets, outputs, and responses to regulatory questions.
  • Oversee statistical programming for Clinical Study Reports (CSRs), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM) databases, including Tables, Figures, and Listings (TFL).
  • Manage statistical programming for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Investigator brochures (IB).
  • Contribute to statistical programming thinking, analysis, and reporting for product and study teams.
  • Develop standard methodologies to enhance quality, efficiency, and effectiveness.
  • Measure compliance with standards and automation usage.
  • Employ project management practices in planning and leading delivery.
  • Hold CRO/partners accountable for maintaining high-quality standards in their deliverables.

Essential Requirements

  • Degree in Mathematics (Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences, or a related field.
  • Strong experience in clinical drug development or healthcare.
  • Advanced skills in SAS programming, knowledge of CDISC standards, and industry best practices.
  • Excellent interpersonal skills and a collaborative mindset.

Desirable Skills/Experience

  • Experience in the Respiratory or Immunology therapeutic area.
  • Familiarity with other programming languages (e.g., S-PLUS, R, Python, XML).
  • Extensive knowledge of Pinnacle 21 Validator.

Why Work with Us?

  • GTAA Top Employer Award for 10 years.
  • Top 100 Employers Award.
  • Canada’s Most Admired Corporate Culture.

Interested in Joining AstraZeneca?

If you're ready to leverage your skills and make a meaningful impact, apply today!

AstraZeneca is an equal opportunity employer committed to diversity and inclusion. We provide a workplace free from discrimination and accommodate persons with disabilities throughout the recruitment process. For assistance, please contact AZCHumanResources@astrazeneca.com.

We embrace diversity and equality of opportunity, building an inclusive team that represents a wide range of perspectives. We welcome applications from all qualified candidates and comply with all applicable laws regarding non-discrimination in employment.