Katalyst Healthcares and Life Sciences
Principal Statistical Programmer
Katalyst Healthcares and Life Sciences, South Plainfield, New Jersey, us, 07080
Responsibilities:
To ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs.Responsible for Statistical Programming activities, including analysing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables; perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/Client); create/QC of CDISC SDTM and Adam files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.Complete full QC validation of in-house created graphs/tables/figures and interact with Statisticians, Programmers, and other members of the clinical team, perform ad hoc analysis, and generate outputs according to the requirements.Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents; participate in operations meetings and address issues that may influence statistical programming and data management.Work with CRO statisticians, statistical programmers and review/QC their work/deliveries; understand clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation; and execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environmentRequirements:
Bachelor's degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or other related Scientific Discipline required.7 years of experience in the job offered or in a related occupation.Demonstrable knowledge of SAS programming language.Demonstrable knowledge of regulatory requirements (FDA, ICH).Demonstrable experience in organizing NDA/s NDA regulatory submissions.Demonstrable experience of extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures.Demonstrable experience of SAS/MACRO, SQL, and SAS/BASE procedures.Demonstrable experience of SAS/GRAPH and Statistical procedures.Demonstrable experience of Clinical data and medical dictionaries.Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected.Demonstrable data structure understanding (tall and wide structures).Demonstrable ability to draft programming requirements from SAP. Demonstrable experience in developing and QC of SDTM, Adam, Define XML and Reviewer's Guide as per the CDISC specifications.Demonstrable experience with study reporting.Demonstrable ability proposing and implementing solutions to technical coding issues.
To ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs.Responsible for Statistical Programming activities, including analysing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables; perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/Client); create/QC of CDISC SDTM and Adam files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.Complete full QC validation of in-house created graphs/tables/figures and interact with Statisticians, Programmers, and other members of the clinical team, perform ad hoc analysis, and generate outputs according to the requirements.Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents; participate in operations meetings and address issues that may influence statistical programming and data management.Work with CRO statisticians, statistical programmers and review/QC their work/deliveries; understand clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation; and execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environmentRequirements:
Bachelor's degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or other related Scientific Discipline required.7 years of experience in the job offered or in a related occupation.Demonstrable knowledge of SAS programming language.Demonstrable knowledge of regulatory requirements (FDA, ICH).Demonstrable experience in organizing NDA/s NDA regulatory submissions.Demonstrable experience of extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures.Demonstrable experience of SAS/MACRO, SQL, and SAS/BASE procedures.Demonstrable experience of SAS/GRAPH and Statistical procedures.Demonstrable experience of Clinical data and medical dictionaries.Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected.Demonstrable data structure understanding (tall and wide structures).Demonstrable ability to draft programming requirements from SAP. Demonstrable experience in developing and QC of SDTM, Adam, Define XML and Reviewer's Guide as per the CDISC specifications.Demonstrable experience with study reporting.Demonstrable ability proposing and implementing solutions to technical coding issues.