Senior Biostatistician

Principal Biostatistician (Canada) Company: Indero (formerly Innovaderm) Location: Montreal, Quebec, Canada Responsibilities 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 role includes ensuring the general financial health of clinical trials, developing Statistical Analysis Plans (SAP; incl. Table, Listing, and Figure [TLF] shells), supporting teams of Statistical Programmers performing statistical analysis of clinical trial data, performing peer‑review of biostatistical deliverables, and acting 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. They 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 training provided to Biostatisticians and/or Statistical Programmers. Specific duties include: Adhere and promote company values, follow SOPs, and complete trainings on time. Act as Lead Biostatistician on multiple Phase 1 to 4 trials, serving as primary point of contact for leads from other departments, sponsors, and third‑party vendors. Be responsible for all statistical aspects of clinical trials. Support teams of Statistical Programmers; manage timelines; review scope and budget; identify out‑of‑scope work; estimate budgets; and monitor financial performance. Provide input into statistical sections of protocols, risk‑based monitoring plans, DM documents, and CSRs. Develop/perform peer‑review of Unblinding Plans, SAPs, and TLF shells. Review and provide input into SDTM/ADaM/derived datasets and CDISC standards. Act as Unblinded Biostatistician for randomization plans, dummy and final lists, and support IDMCs for interim analyses. Provide statistical oversight for programs of Phase 1 to 4 trials, ensure consistency of methodologies and programming, represent Biostatistics in partnership committees, contribute to regulatory submissions, and conduct analyses for investigator‑initiated studies (IIS) and internal R&D projects. Lead internal initiatives to improve efficiency and quality, keep abreast of industry and regulatory guidance, and act as SME and coach. Develop, maintain, and review training and SOPs related to Biostatistics and Statistical Programming. Additional Responsibilities (Optional) Contribute to the development, maintenance, and validation of ADaM and TLF programming. Provide strategic advice on study design, IIS, and internal R&D projects. Interpret and communicate trial results to non‑statisticians. Interact with regulatory agencies and support sponsors for NDAs and other submissions. Attend meetings outside normal business hours as needed. Assume additional duties if qualified and trained. Requirements 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 the Biotechnology, Pharmaceutical, and/or CRO industries. At least 7 years acting as Lead Biostatistician for Phase 1 to 4 trials. Knowledge and Skills Excellent knowledge of drug development process, ICH guidelines (E6(R2), E9, E9(R1)), and Health Canada and FDA regulations. Extensive experience with trial data, SAPs, and TLF shells. Excellent knowledge of CDISC standards. Advanced working knowledge of SAS for analyzing clinical trial data. Experience leading internal initiatives to improve efficiency/quality. Strong organizational, planning, and time‑management skills. Ability to work independently and in a team. Strong verbal and written communication skills in English; French an asset. Benefits Flexible work schedule Permanent full‑time position Complete benefits package (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. Since 2000, Indero has built a strong reputation for the quality of its research and services. EEO Statement Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, 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. Responsabilités (Français) Le Biostatisticien principal agira en tant que biostatisticien responsable pour plusieurs essais cliniques de phases 1 à 4 et/ou assurera la supervision biostatistique de programmes d’essais cliniques de phases 1 à 4. Il fournira son expertise pour les sections statistiques des protocoles (y compris le calcul et la validation de la taille d’échantillon), les plans de surveillance fondés sur les risques (Risk-Based Monitoring Plans), divers documents de gestion des données (Data Management), ainsi que les sections statistiques des rapports d’études cliniques (CSRs). Le Biostatisticien principal veillera également à la bonne santé financière des essais cliniques, élaborera les plans d’analyse statistique (SAP) (incluant les modèles de Tableaux, Listes et Figures [TLF]), soutiendra les équipes de programmeurs statistiques chargées de l’analyse des données d’essais cliniques, effectuera la révision croisée des livrables biostatistiques, et agira en tant que biostatisticien non aveuglé pour la génération des listes de randomisation et les analyses intermédiaires (IAs). Le Biostatisticien principal travaillera en étroite collaboration au sein des équipes d’études biostatistiques et entre départements afin de produire des livrables de la plus haute qualité possible, dans les délais et budgets convenus, et en conformité avec les lignes directrices de l’ICH (International Council for Harmonisation), les normes et recommandations de l’industrie pharmaceutique, les exigences des autorités réglementaires, ainsi que les procédures opérationnelles standard (SOPs) et processus d’Indero. Le Biostatisticien principal dirigera également des initiatives internes visant à améliorer l’efficacité et la qualité des activités et livrables biostatistiques, agira comme expert thématique (Subject Matter Expert – SME) et mentor sur au moins un sujet lié à la biostatistique, et participera au développement et à la mise à jour de formations destinées aux biostatisticiens et/ou programmeurs statistiques. Seniority level Not Applicable Employment type Full‑time Job function Research, Analyst, and Information Technology Industries: Research Services Get notified about new Senior Biostatistician jobs in Montreal, Quebec, Canada. #J-18808-Ljbffr