177 Clinical Development Jobs - Page 8

As a Biostatistician II, you ll perform ad-hoc or exploratory analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Master s degree in statistics or a related discipline. Ph.D. strongly desired. 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO is strongly desired. Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions. Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus. Solid understanding & implementation of CDISC requirements for regulatory submissions. Adept in ADaM specifications generation and QC of datasets. The ability to build strong external & internal relationships and motivate a regional or global team. Effective communicator: able to explain methodology and consequences of decisions in lay terms. As a Biostatistician II, your responsibilities will include: Providing statistical support to clinical studies Participating in the development of study protocols, including participation in study design discussions and sample size calculations Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications Performing statistical analyses and interpreting statistical results Preparing clinical study reports, including integrated summaries for submissions Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.

Job Title - EDC IT Platform Engineer Career Level - D1 AstraZeneca is currently looking for EDC Functional Test Engineer to join our R&D IT : EDC Product Team to help support, manage and maintain our EDC p roduct along with it s numerous integration products . AZ s EDC System is Medidata s Rave, and at AZ is GxP compliant and part of Clinical Development Platforms and is used across late science teams across all therapeutic areas. You will be a part of our BizDevOps team therefore will be responsible to work cross functionally with other team members such as P roduct Lead, DevOps Lead and Release manager & other technical engineers. Key Responsibilities: Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testing of the Core EDC Product , and any data integrations (in and out) of EDC . Perform impact analysis for any change that happens on the EDC system Work with business and perform risk assessment during change implementations/ system upgrades or updates to integrations Follow and participate in validation lifecycle for upgrades, changes, & new integrations Co-develop validation packages in accordance with standard operating procedures (SOPs). Provide support of code review and solution ing for downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Actively participate in business meetings and bring new ideas to the table Responsible to solve day-to-day incidents, service requests and work towards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests, changes and problems. Constantly thrive to learn and upskill according to the organization s goals and demands. Create Gxp Validation Test cases in Jira Xray for system/upgrade testing Perform validation test executions in Jira Xray , for bot h system testing and regression testing. Assist in creating or create UAT test cases that cover the essential business scenarios/use cases for the business . Facilitate process requirements gathering: capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of using Medidata RAVE UI (Classic or Rave EDC) to perform the following actions: Study build, edit checks programming, deployment to production and migration Understanding about different roles and permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services ( eg IVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must have strong communication skills and interpersonal skills Responsible to work on technical tasks to keep the Rave URL(s) and it s integrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. W orking experience in clinical standard and data collection , clinical data conversion or clinical data programming /testing . Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology and FDA/ICH guidelines for clinical study data Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function , SAS programming Knowledge on Coder / Coder+ setup & Lab setup Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter) Hands on Experience of Rave backend data model, sql script writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing test cases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skills e.g : Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDC testing ( Rave/Inform/Veeva) experience. Educational Requirements Bachelor or master s degree in computer science or life science related discipline with IT/CRO/Pharma experience with total of 8 + years of experience Date Posted 18-Feb-2025 Closing Date 30-Mar-2025