Reference #: 11273If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.The Associate Director, Statistical Programming is responsible for all statistical programming aspects of one or more drug development projects and/or acts as technical expert on a project with high business impact. The position is a key leader and will work closely with R&D cross functional team members like Biostatistics, Clinical Data Management, Clinical Operations, Clinical Development, Bioinformatics, etc. in ensuring that pharmaceutical drug-development plans in Jazz are executed efficiently with timely and high-quality deliverables. It is a leader role with strong understanding of drug development process, experience in regulatory activities and key statistical reporting aspects with a track record of operational, organizational and/or technical leadership.

　　Essential FunctionsLead statistical programming activities as product lead for full development project or groups of projects in Oncology Therapeutics.Comply with company, department and CDISC standards and processes, ensuring statistical programming innovations and foster statistical programming solutions, ensure their efficient implementations and knowledge sharing within and outside the project(s).Lead Statistical Programmer on multiple complex projects or products including NDA/BLA and other submissions to regulatory agencies.Lead statistical programming for successful implementation of data transformation to support data visualizations and regulatory submissions.Lead, manage, coach, develop, and support statistical programmers within the Integrated Data Analytics and Statistical Programming (IDASP) team under Data Science Department.Author or provide input to key study-related documents such as Statistical Programming Plan, SAP, CRFs, Data Management Plan, etc.Ensure the quality of statistical programming deliverables, including oversight of CRO biostatistics deliverables.Collaborate with stakeholders and R&D cross functional team members to standardize, maintain and implement the data transformation and statistical analysis requirements.Accountable for timely and quality development and validation of all statistical programming components on assigned project(s). Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.Lead and create data visualization output to enable study teams to identify trends, safety signals, perform data reviews for regulatory submission.Develop and maintain KPIs and escalation pathways to ensure issues are identified, escalated, and prioritized with effective cross-functional action plans to drive quick resolutions.Effectively manage access, risks, and changes by providing technical guidance, while continuously refining methods and processes that will improve the end-user experience.Create functional strategies and specific objectives and develop budgets / policies / procedures to support the functional infrastructure.Participate and/or lead in the development and implementation o SAS programming standards, SOPs and work instructions, including program validation and documentation.Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit.Perform/assess time and resource estimates for project planning, managing timelines for studies/projects

　　Required Knowledge, Skills, and AbilitiesThorough knowledge of statistics and Oncology drug development process.Understanding of SAS programming concepts and techniques in the pharmaceutical industry and ability to correct limitations in strategy proactively.Ability to manage multiple complex projects and assess resource needs.Excellent verbal and written communication within the Biostatistics group and across other functional areas.Excellent SAS Programming skills, and the ability and willingness to work hands on (study level programming support) if necessary.Significant experience in developing SDTM, ADaM and TFLs using SAS or other tools.Expertise with CDISC standards.Good understanding on clinical standards as well as clinical data sets from major EDC systems (e.g., Medidata Rave, INFORM), safety systems (Argus), and CTMS systems.Thorough understanding of clinical data structures, relational database structures, and data exchange with alternative data formats.Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation.In depth understanding of regulatory, industry, and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC].In depth understanding of statistical terminology, clinical tests, medical terminology, Unblinding of trials and protocol designs.Leading change and implementing lean processes, working in matrix environments.Strong project management skills; good communication skills; ability to work in a cross-functional team environment.Knowledge of R, Python Programming and application of ML is a plus.

　　Required/Preferred Education and LicensesBachelor or Master's Degree in Statistics, Mathematics, or related fields; A Master's degree is preferred.10 years in a clinical trial/statistical programming role including 2 years minimum of leadership responsibilities. Experience as a Lead Programmer overseeing the SDTM, ADaM and TFLs activities of support programmers as well as CRO/external vendors.

　　Description of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery.

　　Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel.

　　Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.FOR US-BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages tha