– Onsite NJ
– Initial contract length until 12/31 and potentially renewable
Experience with applying the censoring rules on Oncology studies is preferable. As is efficacy derivations.
• Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
• 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.
• Ensure consistency and adherence to standards within their therapeutic area.
• Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
• Oversee the services provided by CROs.
• Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
• Provide training on departmental SOPs/WPs and standard programs.
• Contribute to the creation of naming conventions and standards for the programming environment.
• Participate in industry wide technical discussions.
KNOWLEDGE, SKILLS & ABILITIES (KSA's):
• Bachelor’s degree in life science, statistics, mathematics, computer science, or related field is required; Master’s degree is preferred.
• 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor’s degree; or 5 plus years experience with a MS/MA degree.
• Experience in ***Oncology*** is best, Hematology Cancer (i.e. CLL) and Medical Affair Projects are preferred.
• Demonstrated proficiency in using SAS to produce derived analysis datasets and produce 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 interpersonal, communication, writing and organizational skills.