Statistical Programming Manager

3 weeks ago

Montreal, Quebec, Canada Innovaderm Research Full time
About the Role

We are seeking a highly skilled Statistical Programming Manager to join our team at Innovaderm Research. As a key member of our Biometrics department, you will be responsible for providing leadership and guidance to our Statistical Programming team, ensuring the delivery of high-quality statistical programming services to our clients.

Key Responsibilities
  • Lead and manage the Statistical Programming team, providing guidance and support to team members to ensure the delivery of high-quality statistical programming services.
  • Develop and implement statistical programming strategies and methodologies to ensure the efficient and effective delivery of statistical programming services.
  • Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Biostatistics, to ensure the seamless delivery of statistical programming services.
  • Develop and maintain statistical programming standards, guidelines, and best practices to ensure consistency and quality across all projects.
  • Provide training and mentorship to team members to ensure they have the necessary skills and knowledge to perform their roles effectively.
  • Stay up-to-date with industry trends, technologies, and methodologies to ensure our team is equipped to deliver the latest and greatest in statistical programming services.
Requirements
  • Bachelor's degree in Statistics, Computing Sciences, or a related field; Master's degree an asset.
  • At least 7 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry, including 5 years of Statistical Programming.
  • At least 1 year of supervisory or project team lead experience preferred.
  • Extended exposure to clinical trial data, SAP, TLF Shells, and specifications.
  • Excellent working knowledge of SAS; SAS certification an asset.
  • Knowledge of XML programming an asset.
  • Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset.
  • Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP.
  • Very organized and detail-oriented, with effective project planning and time management skills.
  • Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
  • Must be able to work independently and as part of a team.
  • Strong verbal and written communication skills in English.
About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We have a solid reputation for the quality of our research and services, exceeding the expectations of our clients. We are committed to providing equitable treatment and equal opportunity to all individuals. We only accept applicants who can legally work in Canada.

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