Experience and responsibilities will include, but are not limited to, the following:
- Provide programming input to CRF, aCRF, SAP, develop or review tables, figures, listings (TFLs) shells. Write or review programming and ADaM specifications and validation plans.
- Provide statistical programming and validation support for SDTM and ADaM data sets, tables, figures, listings, clinical study reports, adhoc analysis requests, clinical data review and data visualization, for Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSURs, PSURs, IB updates, progress reports, electronic submissions, disclosure trial summaries, post-submission activities, and other internal and external requests (e.g., publications).
- Oversee programming activities and deliverables by external vendors and CROs, when necessary, coordinate programming activities among the study programmers to achieve timely progress. Ensure deliverables adhere to company and industry best practices and high quality outputs are delivered within agreed upon timeline.
- Prepare specifications for data analyses by outside vendors and contract research organization (CROs) as required. Assures compliance with the specifications by reviewing the vendors' and CROs’ deliverables.
- Work with external vendors in order to develop and monitor the content and structure of SAS data sets. Access and convert data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).
- Act as a reporting lead and provide oversight between vendors and team supporting reporting needs. Manage and oversee activities of CROs for studies where data management systems work is outsourced.
- Regularly review quality of study data to early identify inconsistencies and anomalies in clinical database. Program data review checks as necessary to facilitate data cleaning activities.
- Perform SAS programming to provide complex data review listings, reports, and data visualization to support different functional groups.
- Ensure consistency and adherence to standards within therapeutic area.
- Develop, implement, and maintain best in class standards, processes, SOPs, SWPs and other related technical documents, and provide training.
- Ensure all programming activities and processes are performed following SOPs, SWPs, regulatory standards and requirements for data submission, and good programming practices.
- Contribute to the creation, maintenance, validation and testing of standard SAS programs, standards for programming tools, outputs and macros using study metadata. Write, update, and maintain documentation. Provide training, guide and coach programmers.
- Design and develop SAS macros, applications, and other tools to expedite SAS programming activities and to support different areas of clinical data review. Seek to make continual improvement to processes and templates used to create technical specifications and to improve process of automation.
- Design and develop visualization tools to assist with clinical data review. Create and maintain programs and outputs and resolves report issues.
- Design and develop standard reporting tools and system utilities.
- Contribute to the creation of naming conventions and standards for the programming environment.
- Establish, develop, contribute to, test and maintain SAS programming environment and system controls, compliant with regulatory requirements to ensure quality, traceability and audit trail.
- Create and maintain all supporting documentation for systems in accordance with processes to ensure quality, traceability, audit trail, and compliance.
- Collaborate with key stakeholders on change control and routine system maintenance.
- Collaborate with information technology groups and other key stakeholders in evaluating and implementing new technologies.
- Collaborate in development of business needs assessments and negotiate effectively to meet technical objectives.
- Participate in system validation, customization, and integration of new tools and technologies.
- Support database build activities (e.g., eCRFs, change requests, edit checks, special actions and functions, derivations, interface configuration, User Acceptance Testing, reports) as needed. Troubleshoot study build issues and system integration issues.
- Understand and analyze complex needs of study team and other stakeholders and identify solutions for data management systems and lead team through process.
- Provide novel and innovative ideas regarding use of data management systems and processes that will improve efficiency, quality, and cost-effectiveness.
- Have expertise to work with end users and technical teams with ease to translate user requirements into workable solutions using the available
Systems and technologies.
- Work with users to prioritize, rationalize and simplify requirements.
- Serve as point of contact for technical support of systems.
- Work independently as well as in teams to accomplish tasks and goals defined.
- Attend required training and self-study and present innovative ideas to improve the programming process and environment.
- Responsible for and assist other team members to adher to quality standards.
- Comply with established SOPs, EMA, FDA, other health authorities, and ICH regulations and policies.
Skills/Knowledge Required:
- Bachelor’s degree in statistics, biostatistics, data science, mathematics, computer science, life science or relevant field is required; Master’s degree is preferred. Strong educational background is expected.
- AT LEAST 8+ years Pharmaceutical/CRO experience as a lead SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor’s degree; or 5+ years similar experience with a MS/MA degree.
- Experience in early phase hematology/oncology a plus.
- Good understanding of different phases of clinical trials, protocols, and CRF designs.
- Demonstrated expert proficiency in using SAS to produce and validate SDTM and ADaM datasets and TFLs.
- Excellent understanding of SAS analytical tools (SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/Macros, SAS/SQL, SAS/Access).
- Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.like JReview, Spotfire, Tableau, and similar tools.
- Solid understanding of relational database structure.
- Versatile knowledge of different EDCs and databases (e.g., Medidata RAVE, ORACLE, Inform) and different data loading systems.
- Demonstrated experience in leading system selection and implementation projects.
- Good knowledge of systems outside of data management including safety systems, Clinical Trial Management systems, and electronic patient reported outcome tools.
- Strong technical and significant experience in developing scalable processes and solutions.
- Excellent working knowledge of FDA, EMA, and other health authorities’ guidelines, regulatory requirements, drug development process.
- Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
- Excellent knowledge of latest CDISC standards and implementation and current FDA data submission process (Define.xml, etc.) is strongly recommended.
- Ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment.
- Demonstrated experience in improving existing approaches by identifying opportunities to creatively transform current industry practices into novel or alternative solutions.
- Excellent organization, time management and attention to detail skills needed to provide high quality and accuracy of deliverables within agreed upon timelines. Ability to maintain
- Demonstrated interpersonal and project management skills.
- Excellent verbal, written and interpersonal communication skills needed to collaborate effectively in a team environment across multiple disciplines, projects, and regions.
- Ability to quickly learn new technologies and disseminate
Company Description:Our Client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, their unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in their own laboratories. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.