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Senior Biostatistical Programmer

2 months ago

Montreal, Quebec, Canada Innovaderm Research Full time

Position Overview:

The Senior Statistical Programmer will oversee one or more clinical studies, taking charge of the design, upkeep, and validation of annotated Case Report Forms (aCRFs). This role includes the creation and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, as well as Tables, Listings, and Figures (TLFs) necessary for various submissions.

Key Responsibilities:

  • Lead the statistical programming efforts for clinical trials, ensuring adherence to timelines and budgets.
  • Review and provide feedback on Statistical Analysis Plans (SAPs) and related documentation.
  • Collaborate with Data Management (DM) teams to support data cleaning and validation processes.
  • Utilize global SAS macros to enhance programming efficiency.
  • Engage in the validation of datasets using Pinnacle 21, ensuring compliance with industry standards.

Collaboration and Quality Assurance:

The Senior Statistical Programmer will work closely with biostatistical teams and various departments to deliver high-quality outputs in line with applicable guidelines and standards. This includes:

  • Maintaining an up-to-date understanding of industry standards and regulatory requirements.
  • Acting as a mentor to junior programmers, fostering their professional development.
  • Participating in internal initiatives aimed at improving programming practices and efficiencies.

About Innovaderm:

At Innovaderm, we pride ourselves on our collaborative and innovative work environment. We are committed to providing equal opportunities and accommodations for all candidates throughout the recruitment process.

Benefits:

  • Flexible work arrangements.
  • Comprehensive benefits package including medical, dental, and retirement plans.
  • Opportunities for ongoing professional development.