Principal Statistical Programmer

<p style="text-align:left"><b>Job Description Summary</b></p>Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting &amp; compliance with timelines.<br><br>Job Description<br><br>Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.<br><br>To do this, we are optimizing and strengthening our processes and ways of working. <br><br>We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.<br><br>We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.<br><br>Apply today and welcome to where we thrive together!<br><br>The Role<br><br>The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high-quality deliverables in Novartis Global Drug Development.<p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Job Description</b></p><p><b>Key Accountabilities:</b></p><ul><li><p>Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development.</p></li><li><p>Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.</p></li><li><p>Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).</p></li><li><p>Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.</p></li><li><p>Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.</p></li><li><p>Provide and implement statistical programming solutions; ensure knowledge sharing.</p></li><li><p>In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.</p></li><li><p>Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.</p></li><li><p>Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.</p></li><li><p>Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.</p></li><li><p>Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance</p></li><li><p>As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.</p></li></ul><p></p><p><b>Your experience:</b></p><ul><li><p>BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field</p></li><li><p>Experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry</p></li><li><p>Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables</p></li><li><p>Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications</p></li><li><p>Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs</p></li><li><p>Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).</p></li><li><p>Good communications and negotiation skills, ability to work well with others globally</p></li><li><p>Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project</p></li></ul><p></p><p><b>Why Novartis:  </b>Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future  together? : <a href="https://www.novartis.com/about/strategy/people-and-culture" target="_blank">https://www.novartis.com/about/strategy/people-and-culture</a></p><p></p><p><b>Commitment to Diversity &amp; Inclusion</b>:</p><p>Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.</p><p></p><p><b>Join our Novartis Network: </b></p><p>Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: <a href="https://talentnetwork.novartis.com/network" target="_blank">https://talentnetwork.novartis.com/network</a> </p><p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Skills Desired</b></p>Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis