Biostatisticien principal/Principal Biostatistician

Principal Biostatistician The Principal Biostatistician will act as Lead Biostatistician on multiple phase 1 to 4 clinical trials and/or Biostatistical Oversight for programs of phase 1 to 4 clinical trials, providing input into the statistical sections of protocols (incl. sample size calculation/validation), Risk-based Monitoring Plans, various Data Management (DM) documents, and statistical sections of clinical study reports (CSRs). The Principal Biostatistician will also ensure the general financial health of clinical trials, develop Statistical Analysis Plans (SAP; incl. Table, Listing, and Figure [TLF] shells), support teams of Statistical Programmers performing statistical analysis of clinical trial data, perform peer-review of biostatistical deliverables, and act as Unblinded Biostatistician for Randomization List and Interim Analyses (IAs). Responsibilities The Principal Biostatistician will work collaboratively within Biostatistics study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero’s standard operating procedures (SOPs) and processes. Lead Biostatistician on multiple Phase 1 to 4 clinical trials. Act as Biostatistics primary point of contact for Leads from other Indero departments, Sponsors, and 3rd party vendors. Be responsible for all statistical aspects of clinical trials. Support teams of Statistical Programmers performing statistical analyses of clinical trials data. Manage timelines of Biostatistics study team deliverables for clinical trials. Review scope of work and budget for Biostatistics study teams at initiation of clinical trials. Proactively identify out of scope (OoS) works throughout the course of clinical trials, provide PMs with budget estimate, and ensure OoS budgets included in Change Orders. Ensure forecast of Biostatistics study teams’ budget is accurate at all times, perform revenue recognition of Biostatistics budgets on a monthly basis, and monitor monthly, project-to-date, and overall HPIs of clinical trials. Review and provide input into statistical sections of protocols (incl. sample size calculations or validation). Participate in development of Risk-based Monitoring Plan for clinical trials. Review and provide input into various DM documents (e.g., eCRF, DVS, DTA) and support DM with data cleaning activities. Develop/Perform peer-review of Unblinding Plans, SAPs, and TLF Shells. Review and provide input into Clinical Data Interchange Standards Consortium (CDISC) SDTM trial domains, ADaM datasets, or derived datasets and all TLFs. Review and provide input into statistical sections of CSRs. Act as Unblinded Biostatistician by developing or reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists for clinical trials and support IDMCs for interim analyses. Act as Biostatistical Oversight for programs of Phase 1 to 4 clinical trials. Ensure consistency of statistical methodologies and programming techniques across studies. Represent the Biostatistics function on Partnership Committees. Take on key statistical responsibilities in the planning and preparation of regulatory submissions. Conduct statistical analysis for Investigator Initiated Studies (IISs) and internal R&D projects. Contribute to the identification of/Lead internal initiatives to increase efficiency/quality of Biostatistics activities. Keep abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance. Act as SME and coach for at least one Biostatistics-related topic. Develop, maintain, and/or review trainings for Biostatisticians and/or Statistical Programmers. Review and provide input into new/revised SOPs related to Biostatistics and/or Statistical Programming activities. May also contribute to the development/maintenance/validation of the statistical programming of ADAMs and TFLs, advise strategically on trial design, review trial results, interact with regulatory agencies, and attend meetings outside of normal business hours. Qualifications Education Master’s degree or PhD in Statistics, Biostatistics, or a related field with applied biostatistics training relevant to clinical trials. Experience At least 10 years of clinical trials experience in Biotechnology, Pharmaceutical, and/or CRO industries. At least 7 years acting as Lead Biostatistician for Phase 1 to 4 clinical trials. Knowledge And Skills Excellent knowledge of drug development process, ICH guidelines, and relevant Health Canada and FDA regulations. Extensive exposure to clinical trial data, SAPs, and TLF shells. Excellent knowledge of CDISC standards and guidelines. Advanced working knowledge of SAS for clinical trial data analysis. Experience leading internal initiatives to improve efficiency/quality an asset. Very organized and detail-oriented with effective project planning and time management skills. Ability to work in high‑speed environment. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English; French an asset. Our Company Indero is a contract research organization (CRO) specialized in dermatology. Based in Montreal, Indero continues to grow and expand in North America and Europe. Flexible work schedule Permanent full‑time position Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) Ongoing learning and development Indero Commitment Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Canada. Seniority level Not Applicable Employment type Full‑time Job function Research, Analyst, and Information Technology Industries Research Services #J-18808-Ljbffr