Job Details

This is Siva from “Silicon Staff”. We have Urgent Openingfor “siva@siliconstaff.comor call me on 248-823-7636 Ext: 108

Position: SAS Programmer

Location: Berkeley Heights NJ

Duration: 6 + Months

CORE JOB FUNCTIONS:

                ·         Provide programming input to CRF, SAP, analysisfile specifications, and tables, figures, and listings (TFLs) shells.

                ·         Write SAS programs to generate derived analysisdatasets, perform analysis, and TFLs.

                ·         Perform ad hoc flexible and rapid programmingarising from questions generated from planned analyses and results.

                ·         Ensure consistency and adherence to standardswithin their therapeutic area.

                ·         Provide programming support for the preparationof integrated reports, submissions and post-submission activities.

                ·         Oversee the services provided by CROs.

                ·         Contribute to the creation, maintenance, andvalidation of standards for programming tools, outputs and macros.

                ·         Provide training on departmental SOPs/WPs andstandard programs.

                ·         Contribute to the creation of naming conventionsand standards for the programming environment.

                ·         Participate in industry wide technicaldiscussions.

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 aSAS Programmer supporting clinical trials for regulatory submissions with aBachelor’s degree; or 5 plus years experience with a MS/MA degree.

                ·         Experience in Oncology, Hematology Cancer (i.e.CLL) and Medical Affair Projects are preferred.

                ·         Demonstrated proficiency in using SAS to producederived analysis datasets and produce TFLs.

                ·         Thorough understanding of clinical datastructures, relational database structures, and data exchange with alternatedata formats.

                ·         Demonstrated skills in using additional softwaretools and applications (e.g. MS office, XML).

                ·         Demonstrated expertise in the handling andprocessing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.

                ·          Demonstrated expertise in providingoutputs 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 teamenvironment with clinical team members.

                ·          Good interpersonal, communication, writingand organizational skills.