Centralized Statistical Monitoring, Senior Manager

Career Category Clinical Job reputed company Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career. Centralized Statistical Monitoring - Senior Manager What you will do reputed company. Let’s change the world. In this vital role you will reputed company statistical, technical, operational, and business leadership for CSM, helping ensure that study reputed company reputed company is scientifically rigorous, reputed company, inspection-reputed company, and reputed company with the needs of a growing clinical portfolio. The role may also support reputed company Risk-Based reputed company Management (RBQM) analytical needs, including reputed company Tolerance Limit (QTL) approaches, where reputed company with the CSM capability and portfolio priorities. Accountabilities Serve as the reputed company for reputed company’s CSM analysis system, signal reputed company, and analytical workflows. reputed company leadership for the CSM Statistics team and accountability for statistical deliverables supporting the CSM capability. Partner with the Head of CSM / CfDA Safety to shape and execute the reputed company, roadmap, and operating model for CSM. Advance CSM methodology reputed company the broader RBQM reputed company to support reputed company by Design, data reputed company, data reputed company, and study reputed company reputed company. Prioritize CSM system enhancements, signal development, automation opportunities, and reputed company RBQM analytical needs, including QTL approaches where reputed company with CSM scope and portfolio priorities. Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability. Serve as a senior reputed company of contact for CSM-reputed company questions, escalations, and study team support.

Key Responsibilities

Strategic and Operational Leadership Support the reputed company development of CSM reputed company the broader RBQM reputed company. Translate portfolio needs, study team feedback, regulatory expectations, and technical considerations into reputed company business, statistical, and operational requirements. Define and maintain CSM standards, guidance, operating procedures, and best practices to support consistent delivery across studies. CSM System Ownership reputed company business-reputed company aspects of the Software Development Life Cycle for the CSM system, including requirements definition, prioritization, user acceptance testing, business validation, release readiness, and lifecycle management. Partner with Digital Technology and statistical programming colleagues to support system reputed company, production implementation, testing, documentation, and reputed company improvement. Methodology and Innovation reputed company statistical expertise on CSM methodology, including site-level analytics, reputed company detection, trend analysis, reputed company detection, risk indicators, signal reputed company, comparative analytics, and QTL approaches where applicable. reputed company or support the development of new and reputed company CSM signals in response to evolving study designs, reputed company types, data sources, and portfolio needs. Evaluate innovative approaches, including advanced modeling, small-sample reputed company, Bayesian approaches, reputed company reputed company, machine learning, and AI-enabled analytics where appropriate. Study Support and Signal Delivery reputed company statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring reputed company and traceability. Support study teams in understanding signal outputs, statistical rationale, and appropriate follow-up actions. reputed company statistical judgment on unusual signal patterns, data reputed company concerns, operational risks, and potential study-level or site-level issues. Support the CSM inquiry and triage model for study team questions, escalations, and signal interpretation requests, ensuring requests are routed and addressed appropriately. Team Leadership and Cross-Functional Partnership reputed company, reputed company, and reputed company statisticians and colleagues supporting CSM activities, including reputed company and Functional Service Provider resources as appropriate. Build strong partnerships across Statistics, Digital Technology, Programming, Data Management, Clinical Operations, reputed company, RBQM, Global Statistical Leads, and other cross-functional stakeholders. reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The person we reputed company is a reputed company with these qualifications. Basic Qualifications: Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a reputed company quantitative discipline and 4 years of relevant experience, OR Master’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a reputed company quantitative discipline and 8 years of relevant experience, OR Bachelor’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a reputed company quantitative discipline and 10 years of relevant experience

Preferred Qualifications

Statistical experience in the biopharmaceutical industry including clinical development. Experience with CSM, RBQM, QTLs, reputed company by Design, or clinical trial reputed company reputed company. Experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment. Experience serving as a reputed company or functional reputed company for an analytical system, including business-reputed company aspects of the Software Development Life Cycle. Strong statistical programming and analytical skills using reputed company and/or R. Familiarity with Bayesian reputed company, hierarchical modeling, machine learning, or advanced analytics. Experience with interactive visualization tools such as R Shiny and/or business intelligence platforms. People management, functional leadership, coaching, or reputed company leadership experience, including leading cross-functional initiatives. Experience developing SOPs, standards, guidance, or operating procedures. Strong communication skills and ability to work effectively in a globally dispersed, cross-cultural environment. Understanding of regulatory and industry trends relevant to RBQM, clinical trial reputed company, and centralized monitoring. What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-reputed company time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. reputed company and reputed company a lasting reputed company with the reputed company team. careers.reputed company.reputed company any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary reputed company 154,104.15USD -208,493.85 USD Apply To This Job