DescriptionThis is for Statistical Programming role Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. Oncology experience preferred.
Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. Perform programming validation to ensure the quality of analysis datasets and programming outputs.
Ensure consistency and adherence to standards within the project. Provide input to the design of the clinical trial database for proper data capture and to ensure data quality. Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.
Provide programming support for the preparation of integrated reports, submissions and post-submission activities. Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets. Serve as the lead programmer in support of NDAs, sNDAs.
Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables. Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
Contribute to the creation, maintenance, and validation of standards for outputs and macros. Provide training on SOPs, WPs and standard programs. Contribute to the creation of naming conventions and development of the programming environment.
Oversee the services provided by CROs. Skills/Knowledge Required: Bachelors Degree in life science, statistics, mathematics, computer science, or related field is required; Masters Degree is preferred. 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions or equivalent experience.
Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats. Demonstrated skills in using additional software tools and applications (e.g.
MS office, XML). Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. In-depth understanding of regulatory, industry, and technology standards and requirements.
Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Good planning and project management skills.
Good interpersonal, communication, writing and organizational skills.#LI-NV1EEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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