Hi ,
Hope you are doing great. I have an urgent position with my direct client, if you are interested kindly revert me with your updated resume. *Job Title = Programmer, Statistical Contract* *Duration= 12 months + (possible extension) * *Location = Berkeley Heights, NJ* *Type – C2C* *JOB DESCRIPTION* *Responsibilities will include, but are not limited to, the following:* · 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. · 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:* · Bachelor's Degree in life science, statistics, mathematics, computer science, or related field is required; Master's Degree is preferred. · 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions. · 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. · JAPAN submission experience is a Plus Best Regards. Himanshu Sharma Aequor Technologies 377 Hoes Lane Piscataway, New Jersey 08854 Work: 732-659-9199 extn 2002 Direct #732-412-9311 email: [email protected] *URL: *http://aequor.com/ -- You received this message because you are subscribed to the Google Groups "Hot List" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/directclienteq. For more options, visit https://groups.google.com/d/optout.
