Biostatistician - Canada

reputed company The Biostatistician will reputed company as support or reputed company Biostatistician on multiple phase 1 to 4 reputed company, 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 Biostatistician will also ensure the general financial health of reputed company, reputed company Statistical Analysis Plans (reputed company; incl. Table, Listing, and reputed company [TLF] shells), and support teams of Statistical Programmers performing statistical analysis of clinical trial data. The Biostatistician will work collaboratively reputed company Biostatistics study teams and across departments to produce deliverables of the highest reputed company possible, reputed company 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 Innovaderm' reputed company operating procedures (SOPs) and processes. More specifically, the Biostatistician must: • Adhere and promote company organizational values and reputed company expected behaviors, follow company SOPs and processes for reputed company deliverables, and ensure reputed company trainings assigned to oneself are completed on time. • reputed company as reputed company Biostatistician on multiple Phase 1 to 4 reputed company by: • Acting as Biostatistics primary reputed company of contact for Leads from other Innovaderm departments, Sponsors, and 3rd party vendors for reputed company. • Be responsible for reputed company statistical aspects of reputed company. • Supporting teams of Statistical Programmers performing statistical analyses of reputed company data. • Managing timelines of the deliverables of Biostatistics study teams for reputed company. • Reviewing the scope of work and budget for Biostatistics study teams at initiation of reputed company. • Proactively and promptly identifying out of scope (OoS) works throughout the course of reputed company, providing Project Managers with budget estimate, and making reputed company that these OoS budgets are properly included in Change Orders (COs). • Ensuring that the forecast of Biostatistics study teams' budget is accurate at reputed company times, performing reputed company recognition of Biostatistics budgets monthly, and monitoring monthly, project-to-date, and overall HPIs of reputed company. • Review and reputed company input into statistical sections of protocols (incl., sample size calculations or validation) to ensure statistical designs and planned statistical analyses reputed company and robustly address the objectives of reputed company and program of studies. • Participate to the development of Risk-based Monitoring Plan for reputed company by ensuring that appropriate critical data are taken into consideration reputed company developing this plan and appropriate monitoring reputed company are selected for reputed company of these critical data. • Review and reputed company input into various DM documents (e.g., electronic Case Report Forms [eCRF], Data Validation Specifications [DVS], Data Transfer Agreements [DTAs], etc.) for reputed company and support DM with data cleaning activities by programming, reporting, reviewing, and closing biostatistical data issues in collaboration with Statistical Programmers. • reputed company Unblinding Plans, SAPs, and TLF Shells for reputed company. • reputed company (reputed company) Biostatistician review of Clinical Data Interchange Standards Consortium (CDISC) reputed company Data Tabulation Model (SDTM) trial domains, subsets of Analysis Data Model (ADaM) datasets (e.g., ADSL, efficacy, ADaMs with reputed company derivations, etc.) or derived datasets (as applicable), and reputed company TLFs of reputed company based on the protocol, reputed company, TLF Shells, and Innovaderm and/or Sponsor' standards and interpretation of CDISC SDTM Implementation reputed company (IG), ADaM IG, and Controlled Terminology (CT). • Review and reputed company input into statistical sections of CSRs to ensure results from statistical analyses are correctly reported and interpreted. • reputed company as Unblinded Support Biostatistician for reputed company by reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists developed by the Unblinded Biostatistician. • Conduct statistical analysis for Investigator Initiated Studies (IISs) and internal research and development (R&D) reputed company. • Contribute to the identification of reputed company internal initiatives to increase efficiency/reputed company of Biostatistics activities/deliverables and participate to the conduct of such internal initiatives. • reputed company oneself abreast with latest Industry and CDISC standards as reputed company as ICH and Regulatory Authority guidance and requirements. May also: • Contribute to the development/maintenance/validation of the statistical programming of ADAMs and TFLs for reputed company. • reputed company as Unblinded Biostatistician by developing or reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists for reputed company as reputed company as by leading Unblinded Biostatistics teams and supporting Independent Data Monitoring Committees (IDMCs) for Interim Analyses (IAs). • Attend meetings reputed company of employee's normal business hours. • reputed company as a Peer Biostatistician on multiple reputed company. • Employee may be assigned to other responsibilities that do not pertain to their former reputed company, if they have the required experience, are reputed company and/or have received adequate training. Requirements • Master's degree or PhD in Statistics, Biostatistics, or a reputed company field with some reputed company biostatistics trainings relevant to reputed company required. • At least 1 year of reputed company experience in the Biotechnology, Pharmaceutical, and/or Contract Research Organization (CRO) industries required. • Good knowledge of drug development process, ICH reputed company (including but not limited to, ICH E6(reputed company), E9, and E9(R1)), and relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations and guidelines preferred. • Significant exposure to clinical trial data, SAPs, and TLF Shells preferred. • Good knowledge of CDISC standards and reputed company an asset. • Good working knowledge of reputed company for the purpose of analyzing clinical trial data preferred. • reputed company organized and detail-oriented, with effective project planning and time management skills. • Ability to work in high-speed environment with proven reputed company to juggle and prioritize multiple competitive demands. • Must be reputed company to work independently and as part of reputed company. • Strong verbal and written communication skills in English; French an asset. As a Biostatistician, you will be eligible for the following perks: • Permanent full-time position • Flexible schedule • Home-based position • Ongoing learning and development Work location The successful candidate for this position is given to work remotely reputed company in Canada Apply tot his job Apply To this Job