Principal Statistical Analyst

4 weeks ago

Montreal, Quebec, Canada Innovaderm Research Full time

Position Overview: The Lead Statistical Programmer will oversee one or more clinical studies and will be accountable for the creation, upkeep, and validation of annotated Case Report Forms (aCRFs), along with the specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, Tables, Listings, and Figures (TLFs), as well as submission packages necessary for various purposes including data review meetings and clinical study reports.

Key Responsibilities:

  • Ensure adherence to company values and expected behaviors, follow standard operating procedures (SOPs) for all deliverables, and complete all assigned training in a timely manner.
  • Act as the Lead Statistical Programmer on multiple individual studies.
  • Evaluate the statistical programming scope of work and budget at the start of clinical trials, identifying any tasks that fall outside the defined scope.
  • Review and provide insights on various Data Management documents, Statistical Analysis Plans (SAPs), and TLF Shells.
  • Assist Data Management with data cleaning activities by programming, reporting, reviewing, and resolving statistical data issues in collaboration with other Statistical Programmers and the Lead Biostatistician.
  • Develop, maintain, and validate aCRFs in accordance with protocols and company standards.
  • Generate and validate specifications and statistical programming for SDTMs, ADaMs, and TLFs based on established guidelines.
  • Utilize Pinnacle 21 for the validation of SDTMs, ADaMs, and define.XMLs, addressing any discrepancies appropriately.
  • Employ global SAS macros to enhance the efficiency of statistical programming processes.
  • Contribute to the identification of future internal initiatives aimed at improving the efficiency and quality of statistical programming activities.
  • Stay updated with the latest industry standards and regulatory guidelines.

Qualifications:

  • Bachelor's degree in Statistics, Computing Sciences, or a related field; a Master's degree is a plus.
  • A minimum of 7 years of experience in clinical research within the biotechnology or pharmaceutical industry, including 5 years in statistical programming and 2 years as a Lead Statistical Programmer.
  • Strong knowledge of clinical trial data, SAPs, and specifications.
  • Proficient in SAS; SAS certification is advantageous.
  • Familiarity with CDISC standards and guidelines; CDISC certification is a plus.
  • Excellent organizational skills and attention to detail, with effective project planning and time management abilities.
  • Strong verbal and written communication skills in English; proficiency in French is an asset.

About Innovaderm: Innovaderm is a contract research organization (CRO) specializing in dermatology, known for its commitment to quality research and services. We provide a collaborative and innovative work environment, offering attractive advancement opportunities.

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