Lead Statistical Programmer - Sponsor Dedicated

<p>As a <b>Lead Statistical Programmer</b> in our <b>sponsor-dedicated</b> Flexible Solutions business unit, you are central to the successful delivery of complex projects for a renowned, innovative and global top pharmaceutical company.</p><div><p></p><p>You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. It is a great opportunity to see more how this works from a Big Pharma perspective, whilst still being part of a global CRO with opportunity for future career growth.</p><p></p><p><b>You can be 100% home-based in EMEA or, if you prefer, you can work from our local office in your home country. </b></p><p></p><p><b>Your Responsibilities:</b></p><ul><li><p>Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.</p></li><li><p>Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs.</p></li><li><p>Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses.</p></li><li><p>Support/oversee submission activities (especially in late phase team).</p></li><li><p>Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times.</p></li><li><p>Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes.</p></li></ul><p></p><p><b>Your Profile:</b></p><ul><li><p>Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.</p></li><li><p><b>In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company.</b></p></li><li><p><b>Solid experience with complex clinical trials (minimum 5 years) and the corresponding datasets’ content (safety and efficacy) and endpoints.</b></p></li><li><p><b>Previous Lead experience preferred.</b></p></li><li><p>Ideally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.</p></li><li><p>Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs.</p></li><li><p>Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer&#39;s Guides and submission standards.</p></li><li><p>An autonomous, collaborative work style, a curious mind and a keen attention to detail.</p></li><li><p>Fluency in English – both verbal and written – is a must.</p></li></ul></div><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>