Innovations technological

Location:            Warren, NJ

Duration:            6+ months

Best Rate:           $60/hr

Interview:           Phone screen then F2F interview

 

Job Description:

 

SAS / Clinical Programmer

Skills/Knowledge Required:

•             Bachelor's degree in life science, statistics, mathematics, computer science, or related field is required; Master's degree is preferred.

•             9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 8 plus years experience with a MS/MA degree.

•             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.

•             Excellent planning and project management skills.

•             Good interpersonal, communication, writing and organizational skills.

•             Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC.

 

Responsibilities will include, but are not limited to, the following:

1. Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.

2. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.

3. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.

4. Ensure consistency and adherence to standards within their therapeutic area.

5. Provide programming support for the preparation of integrated reports, submissions and post-submission activities.

6. Serve as the lead programmer in support of NDAs, sNDAs.

7. Oversee the services provided by CROs.

8. Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.

9. Provide training on departmental SOPs/WPs and standard programs.

10. Contribute to the creation of naming conventions and standards for the programming environment.

11. Participate in industry wide technical discussions.

Thanks & Regards,

Sandeep Kumar (Team Lead)

US Office: IDC Technologies, Inc.,1851 McCarthy Boulevard, Suite 116, Milpitas, CA , USA, 95035 

Phone: 408-457-9399 Ext 2026 I Email: skumar@idctechnologies.com I GTalk: sandeep.100ni | Web: www.idctechnologies.com 

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