Principal Scientist Global Data and Bioinformatics
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Newark, DE 19711
As a principal scientist global data and bioinformatics, position is responsible for coordinating with the data management and statistical heads within the QPS data and statistical centers in creating and maintaining Enterprise level (global) standards for clinical data, data transfers from external vendors, CDISC-compliant database nomenclature, SDTM output in data sets and data transfer files. Associated with this responsibility will be oversight with the QPS clinical sites in the creation of global standard operating procedures for and quality management of processes of data management and statistical programming. In addition, as a statistical programmer this position will assist when requested and able with client related statistical programming for clinical data, and the preparation of WinNonlin and NONMEM pre- and post-analysis files.
Enterprise (Global) Responsibilities
• Responsible for creating and maintaining a global eCRF library based on CDASH standards for paper, eCRF and/or full EDC based systems, facilitate creation of SDTM compliant datasets, and globally assist statistical programming in implementing ADaM data standards
• Oversee, coordinate and support data management and statistical programming activities in the creation of standard SAS macros for analysis and reporting of data; set standards for global SAS programs/tools or SQL/SRS programs that assist QPS data management and statistics to provide the highest quality outputs for database and statistical programming services
• Support QPS Clinical Research Services in maintaining operational excellence in the use of OpenClinica and other eCRF and EDC systems that QPS uses or will use.
• Oversee and support QPS Data Management in the creation and maintenance of OpenClinica Excel loaders that are CDASH compliant, SDTM-convertible, globally applicable, and contain internal validation programming scripts
• Provide input and support to the creation of Standard Operating Procedures in Data Management, Statistics and Pharmacometrics related to the creation and maintenance of global data, statistical and pharmacokinetic standards
• Ensure compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
• Provide a high level of effective collaboration (and oversight when required) for statistical programming initiatives with the operation teams of CRS global data management, biostatistics, global pharmacometrics, medical writing, and the QPS clinical sites
• As a statistical programmer produce submission-ready electronic datasets, tables, figures, listings and documentation that support and match planned work product and project deadlines.
• Mentor other statistical programmers as designated
• Such other responsibilities and projects that the Company may assign.
Competencies (“soft skills”, traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)
- Concern for Impact
- Concern for Standards
Knowledge/Skills/Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)
- SAS Programming Expertise: The position necessitates proficiency in SAS BASE, SAS STAT, SAS/GRAPH, SAS Macros, PROC SQL, and CDISC standards. Expert knowledge of structured programming principles and practice is needed. The position mandates a strong programming expertise in clinical trials with experience in CDISC SDTM and ADaM dataset/spec generation.
- SAS Programming Duties:
- The position requires that the principal scientist program, validate, maintain, and document statistical analysis programs for clinical trials based on the statistical analysis plan (SAP) and other specified trial documents following QPS standards and SOPs. The position must be able to develop specifications for SDTM and ADaM datasets, pooled data sets, and TFLs and ensure that submission and trial data sets (SDTM and ADaM), TFLs, and other specified output are created in the most efficient manner and meet regulatory standards. The position demands compliance with regulatory standards, validation of work output, and reporting of trial results. The position must be able to direct and provide oversight of statistical programming resources for clinical trials when such responsibility is delegated to them.
- CDISC (SDTM & ADaM) Expertise: The position acts as an expert in the use and application of SDTM and ADaM including: 1) a full knowledge of CDISC terminology and architecture for both SDTM and ADaM; 2) an ability to mentor on CDISC Standards; 3) a proficiency in the creation of programming tools to competently develop study-specific SDTM and ADaM data sets; 4) the capability to develop and advise programming and statistical teams on complex derived trial outcomes for ADaM data sets; and, 5) the expertise to develop and support SDTM safety data pools.
- Communications Skills: The position requires superior oral and written communications skills in English with a demonstrated effectiveness to communicate with project teams, data managers, statistical programmers, statisticians, and sponsors. The position demands excellent listening and comprehension skills, with the ability to feedback information received to management. The position involves specific use of active listening skills to mentor colleagues and solve issues. The position should have demonstrated communications skills to deliver expert consultation and mentoring.
- Problem Solving Skills: The position requires expert problem solving skills. The position should be able to expertly identify and prevent programming problems including: logic errors and warnings; inferential statistics programming logic, including appropriate choice of statistical testing; and the appropriate use of trial and program specific macros. The position is required to understand the need to seek assistance and consultation for more complex problems and should be able to write and train staff on new documentation addressing problems and issues.
- Project Management Skills: The position should have expert time management skills and be able to independently identify and set multiple project level tasks to be completed including: defining scope of work (SOW); defining timelines and key project related work product deliveries; identifying critical path issues and items; understanding risk assessment and being able to create risk mitigation strategies; and identify internal (and external) resources required to complete the work. A key ability is prioritization and balance of workload to meet timelines, but without supervision.
Education/Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)
Bachelor’s Degree Biological Sciences or Information Technology with 8+ years related experience