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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 and follow @Jazz Pharma on Twitter. Brief Description: The Senior Principal Statistical Programmer provides Statistical Programming technical leadership and support to team members. The Senior Principal Statistical
Programmer is responsible for developing all aspects of statistical programming deliverables for the analysis of clinical study data in accordance with departmental SOPs and guidelines.
Delegates tasks appropriately and tracks progress. The Senior Principal Statistical Programmer may also construct estimates of project resource requirements and timelines and routinely briefs management on accomplishments, status of projects, and any issues. In addition, the Senior Principal Statistical Programmer will be a designated member of CTWG team in the role of lead Statistical Programmer for clinical trial(s). Essential Functions Lead statistical programming activities as product lead for full
development project or groups of projects in Oncology Therapeutics.
Attend multi-disciplinary team meetings, representing the statistical programming function. Create or review and approve statistical programming plans at study and project level. Provide input on key study-related documents produced by other functions (e. g. CRFs, Data Management Plan, SAPs, etc. ). Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation.
Develop and validate programs (SAS or R) to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies. Collaborate with stakeholders and R&D cross functional team members to standardize, maintain and implement the data transformation and statistical analysis requirements. Assist statisticians by suggesting algorithms to address novel analysis requests. Create and document archives of statistical programming deliverables, outputs, and analysis files. Create and maintain department SOPs related to statistical programming. Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
Oversee work of internal contract programmers and external vendors. Provide time and resource estimates for project planning. Required Knowledge, Skills, and Abilities Minimum of 9 years of experience in developing statistical programming deliverables for clinical trials using the SAS system. Skilled in programming with SAS. Knowledge of additional programming languages a plus. Good knowledge of statistics and Oncology drug development process. Ability to manage multiple complex projects and backss resource needs.
Excellent verbal and written communication within the Biostatistics group and across other functional areas. Significant experience in developing SDTM, ADa M 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. Experience as a lead programmer for NDAs/BLAs. Experience overseeing the work of internal contractors and external vendors (CROs). Experience in pharmacokinetics/pharmacodynamics modeling a plus.
Required/Preferred Education and Licenses Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master's Degree preferred. Jazz medicals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US-BASED CANDIDATES ONLY Jazz medicals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
For this role, the anticipated base pay range is $144,000-$189,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: careers. /benefits
the development and availability of life-saving therapies for patients in need. - -Working at Wu Xi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients.
Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. - -Our parent company, Wu Xi App Tec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally Wu Xi App Tec spans to more -than 39,000 employees with 32 facilities in 9 countries. - -The Senior Business Analyst provides in process analysis, process and system
design, systems development, configuration, testing, implementation and training to support the ERP functions of our business stakeholders according to specification and schedules while meeting quality requirements.
The Sr. BA is also adept at building cross-functional relationships while working with a high degree of autonomy and can assist senior IT Management with the guidance of the team where necessary. --- Provide technical support and analysis directly within SAP B1 (MRP/WMS), and related integration knowledge between SAP B1 and STARLIMS, Microsoft Dynamics GP and CRM. --- Secondary knowledge of Microsoft SQL Reporting Services, Crystal Reports, and other third party tools. ---
Learn and understand existing systems and business processes; develop and maintain a robust awareness of how the business operations work and help stakeholders explore technology possibilities to more effectively execute in their roles.
--- Work in partnership with stakeholders to improve business processes impacted by technology changes. --- Take on complex, high-profile projects. --- Perform enterprise analysis by planning and scoping several inter-related initiatives and helping senior-level business stakeholders make informed decisions about which initiatives to execute and how to execute. --- Mentor associate and mid-level business analysts in the organization.
--- Lead and facilitate teams of cross-functional subject matter experts. Build strong and positive working relationships with all functional areas across the company and understand their needs. --- Use techniques such as focus groups and requirements workshops to elicit, analyze, and document clear and concise user requirements/stories in collaboration with business departments to achieve their desired results for system features or process changes. --- Use visual modeling techniques such as work-flow diagrams or wireframe prototypes to identify gaps between business requirements and existing technology solutions.
--- Assist with functional requirements specification using system analysis techniques and methods. --- Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements. --- Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead user acceptance testing (UAT) efforts to ensure the software implementation meets the needs of business end users. Maintain a log of any issues identified during testing. --- Assist with Integration testing effort for SAP System to other application and ERP Systems.
Review Requirement documents (test basis), mentor test scenario preparation and execution and secure Acceptance sign offs--- Facilitates testing execution and develops test evidence --- Manage requirements changes and ensure appropriate stakeholders are involved in all decisions about change. --- Review and validate deliverables with appropriate business and technology stakeholders. --- Train end users to ensure they understand all process and procedural changes. Collaborate with training staff to create appropriate training materials and deliver the training.
Collaborate with business users to update other organizational assets impacted by business process and technology changes. --- Use project management skills to manage the business analysis effort. Be proactive and dependency-aware and contribute to the project implementation plan. Manage to commitments and deadlines. --- Post-implementation, evaluate progress made against the business objectives for a project to show the extent to which they were fulfilled. Suggest follow-up projects and initiatives as needed to fully realize the intended objectives.
--- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. --- Maybe required to work Holidays and weekends--- Contributes to the overall operations and to the achievement of departmental goals--- Perform job specific tasks in compliance with applicable Regulations, International Standards, and Wu Xi App Tec Policies and Standard Operating Procedures. --- Write risks backssments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan. --- Provide Quality oversight, review, and approve Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports and Change Controls--- Participate with Change Control initiatives as related to computer systems.
--- Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11--- Develop and execute documentation for validation and qualification activities to support various computer system validation projects.
--- Documents to be authored may include VMP, URS, FRS, PQ, etc. --- Ensure compliance of computerized systems to relevant regulatory requirements (e. g. c GMP/GLP/GAMP/GALP). --- Draft templates for High level Risk backssments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports. --- Acts as liaison between Quality Assurance and project team to assure that Gx P software is implemented in compliance with applicable regulations and guidelines. --- Manage the full lifecycle of system validation projects; ensure the delivery of quality validation deliverables throughout the lifecycle of the SAP program--- Develop and manage Gx P system lifecycle documentation, including Validation Master Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrices, Validation Reports, SOPs, Change Control Documentation, and Risk backssment reports--- 8+ years of relevant experience or equivalent--- Bachelors' degree or equivalent experience -Knowledge / Skills / Abilities: --- 8+ years of experience performing business analysis and supporting major business applications.
--- ERP (SAP ECC or SAP B1) Implementation experience --- Hand On SAP Functional analysis and configuration experience --- Functional testing , User Acceptance testing and Validation work in SAP System--- Integration SAP system to different ERP (Non SAP) Systems --- SAP system cutover activities --- SAP testing experience - Functional Unit test, Integration test, UAT (User Acceptance Test) --- Waterfall or Agile business analysis experience--- Lean six sigma experience preferred--- Leadership and facilitation skills--- Detail-oriented with expertise in problem solving, analytical and critical thinking skills--- Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines in a fast-paced environment--- Ability to receive, comprehend, and effectively communicate detailed information through verbal and written communication--- Ability to communicate with all levels of the organization--- Ability to work well within a team environment--- Proficient in Oral & Written communication skills--- Proficient in Microsoft (Excel, Word, Outlook, Power Point, Visio) -Our Values: Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
-Our greatest asset is our people, Wu Xi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team. -Wu Xi App Tec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, interactionual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. -
through a Graph QL API. We take pride in delivering highly reliable and scalable solutions. We're always looking for ways to not only improve our knowledge but also share knowledge throughout the company. About the Work As a key member of our Payments team you will: Working with our preferred technology stack (Primarily Elixir/Phoenix, Live View).
Collaborate regularly with engineers, product managers, designers to bring new features and products to our patrons. Develop, scale, and optimize amazing Graph QL & RESTful APIs. Design and build foundational components that improve the reliability and scalability of our backend services. Solve technical problems of the highest scope and complexity.
Strive to reduce technical debt, while communicating with teammates about any larger refactor. Be part of our backend service teams supporting web and mobile clients.
Participate in the design, architecture, and delivery of new features in a collaborative agile/scrum environment. Collaborate with the team to define and improve our documentation, internal style guide, maintainability and best practices. Actively participate in Engineering efforts that help streamline the experience of our payments product Provide mentorship to other developers on the team. Other duties as required. About You A solid foundation in computer science, with strong competencies in data structures, distributed
systems, algorithms and software design. Passionate about clean code architecture and software craftsmanship.
Experience with a modern web framework and consuming and building APIs. Experience with Git and Git Hub or similar. A strong grasp and experience with relational databases; including Postgre SQL An interest in designing, building, and optimizing distributed systems. Excellent communication skills, including solid technical writing abilities. A drive for finding simple solutions to complex problems. Knowledge and familiarity with caching strategies and tools. Always trying to understand problems from a fundamental perspective Experience with testing frameworks such as Ex Unit, RSpec, Jest, pytest or equivalent.
NICE TO HAVE: Experience with Kubernetes, Kafka, g RPC, experience with functional programming and experience or excitement about the payments industry. What We Offer Competitive compensation package. Comprehensive Benefits package. Fun, relaxed work environment. Education and conference reimbursements. #LI-REMOTE#LI-HYBRID #J-18808-Ljbffr
