Principal Biostatistician (North & South America)

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    "datePosted": "2025-07-21",
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    "description": "<p><span style=\"font-size: 10pt\">The Bioforum Biometrics department is growing, and we have an opportunity for an experienced biostatistician to join our group. This position is for candidates located in either <span style=\"font-weight: bold\">North America (including Canada) or South America (remote)</span>.</span></p>\n<p> </p>\n<p><span style=\"font-weight: bold\"><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Purpose</span></span><span style=\"color: rgb(34, 34, 34); font-size: 13px\">: Works alongside the Director: Biostatistics to provide biostatistical support and services related to clinical trials. Act as Statistical Lead on clinical trials. </span></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 13px\">  </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Required skills:</span></span></p>\n<ul>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Minimum 8 years’ experience as a biostatistician working on clinical trials.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Knowledge of advanced statistical methodology used in the analysis of clinical trial data</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines)</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Study / Project lead / Customer interaction experience</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Attention to detail.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Excellent communication skills.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">An Honours degree (a Masters degree / Ph.D will be an advantage) in a statistics related field.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Experience interacting with a regulatory agency will be an advantage</span></li>\n</ul>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 13px\"> </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Duties will include:</span></span></p>\n<ul>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Ownership of the statistical aspects and requirements on clinical trials done by Bioforum. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Provide guidance on study designs and statistical methodology as appropriate. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Interact with the customer and provide guidance / input on the statistical requirements and queries in the planning and during the conduct of the trial. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Statistical review and preparation of documentation, including the statistics section of the study protocol, Statistical Analysis Plan, and statistical sections / results interpretation of Clinical Study Reports (CSRs). </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Provide training/mentorship to junior statisticians. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Review Table, Listing and Figure (TLF) shells associated with the study SAP.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Review ADaM and/or derived dataset specifications as required.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Development of SAS programs for study TLFs focussing on efficacy and/or advanced statistical methodology.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Review statistical output produced by the statistical programming team.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 13px\">Contribute to department wide initiatives to improve quality and efficiency.</span></li>\n</ul>",
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