Job
Description
You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may independently provide timely and professional leadership of special projects that focus on innovative tools and systems. You will strategically and tactically support the Director Clinical Data Standards and be responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Your role will also involve providing expert support and stellar customer focus to business users and teams on their use of data standard collection tools, data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. You may also lead global teams as required. At the study level, you will be responsible for all statistical tasks on assigned clinical or non-clinical trials, particularly for high complexity trials, seeking peer input/review as required. You will contribute to protocol development, statistical analysis plan development, and reporting activities. Additionally, you will provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. You will independently lead interactions with external review boards/ethics committees, external consultants, and represent the organization in statistical discussions at external congresses, conferences, and scientific meetings. You will be responsible for strategic statistical input into one or more projects, collaborating with clinical, regulatory, and other strategic functions to drive quantitative decision-making in drug development. At the disease area/TA/indication level, you will drive strategic statistical input and excellence to development programs within the assigned areas. Additionally, you may lead or significantly contribute to initiatives at the global line function level or cross-functional franchise level, requiring coordination of diverse team members. You will actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives and represent the organization in due diligence teams for in-licensing opportunities. The ideal candidate will have an MS (in Statistics or equivalent) with 10+ years of relevant work experience or a PhD with 6+ years of relevant work experience. Strong interpersonal and communication skills, along with proven expertise in statistics and its application to clinical trials, are essential. Additionally, experience with statistical software packages such as SAS or R, and a strong understanding of drug development and Health Authority guidelines are required. The role may also require expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Novartis is committed to providing reasonable accommodation to individuals with disabilities. For more information or to request accommodation during the recruitment process, please contact [email protected] and include the job requisition number in your message.,
