Biostatisticien principal

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). 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. The Principal Biostatistician will also lead internal initiatives to increase efficiency / quality of Biostatistics activities / deliverables, act as Subject Matter Expert (SME) and coach for at least one Biostatistics-related topic, and develop / maintain (new) trainings provided to Biostatisticians and / or Statistical Programmers. Responsibilities Act as Lead Biostatistician on multiple phase 1 to 4 clinical trials. Serve as primary point of contact for Biostatistics with other Indero departments, sponsors and third‑party vendors. Own all statistical aspects of clinical trials. Support Statistical Programmer teams in performing statistical analyses. Manage timelines for Biostatistics study‑team deliverables. Review scope of work and budget for Biostatistics study teams at trial initiation. Identify out‑of‑scope work, provide budget estimates, and ensure inclusion in Change Orders. Maintain accurate forecast of Biostatistics team budget; perform monthly revenue recognition and monitor HPIs. Provide input into statistical sections of protocols, including sample‑size calculations or validation. Help develop Risk‑Based Monitoring Plans and ensure critical data are considered. Review DM documents (eCRF, DVS, DTA, etc.) and support data‑cleaning activities. Develop and peer‑review Randomization Plans, SAPs, and TLF shells. Review or peer‑review CDISC SDTM domains, ADaM datasets, and all TLFs according to protocol, SAP, and CDISC guidelines. Review statistical sections of CSRs to ensure correct reporting and interpretation. Act as Unblinded Biostatistician for Randomization Lists and Interim Analyses, and lead IDMC support. Provide Biostatistical Oversight for phase 1‑4 program portfolios. Represent the Biostatistics function on partnership committees. Take key statistical responsibilities in regulatory submission planning. Conduct analyses for Investigator‑Initiated Studies (IISs) and internal R&D projects. Lead internal initiatives to improve efficiency and quality of Biostatistics activities. Stay current with industry standards and regulatory guidelines. Act as SME and coach for at least one Biostatistics topic. Develop, maintain, and review trainings for Biostatisticians and Statistical Programmers. Review and provide input on new or revised SOPs related to Biostatistics and Statistical Programming. Qualifications Master’s or PhD in Statistics, Biostatistics, or related field with applied clinical‑trial biostatistics training. Minimum 10 years of clinical‑trial experience in biotechnology, pharmaceutical, or CRO settings. At least 7 years as Lead Biostatistician for phase 1‑4 trials. Excellent knowledge of drug development, ICH guidelines (E6(R2), E9, E9(R1)), Health Canada and FDA regulations. Strong experience with clinical‑trial data, SAPs, and TLF shells. Proficiency in CDISC standards and guidelines. Advanced working knowledge of SAS for clinical‑trial data analysis. Experience leading initiatives that improve efficiency and quality of biostatistical work. Organized, detail‑oriented, with strong project‑planning and time‑management skills. Ability to work autonomously and collaboratively in a multidisciplinary team. Excellent oral and written communication skills in English; fluency or strong knowledge of French is an asset. Preferred Qualifications Experience with investigational studies and internal R&D projects. Knowledge of CDISC SDTM and ADaM IGs, and Controlled Terminology. Experience with regulatory submissions and interaction with agencies (e.g., NDAs, IDMCs). Benefits and Perks Flexible work schedule. Permanent full‑time position. Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public‑transportation rebates, social activities). Ongoing learning and development opportunities. About Indero Indero is a contract research organization (CRO) specialized in dermatology. Founded in 2000 and based in Montreal, Indero has grown across North America and Europe, delivering high‑quality research and services that exceed client expectations. Equal Employment Opportunity 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. #J-18808-Ljbffr