Principal Statistical Programmer

Proclinical, in support of our client, are seeking an individual to fill the role of Principal Statistical Programmer, based in Boston, MA. The successful candidate will be responsible for all statistical programming deliverables in support of the design, conduct, analysis and reporting phase of one or more clinical trials.

Responsibilities

• Lead SDTM mapping activities working closely with CRO, DM and Stats.
• Review SDTM mapping specs, aCRF, datasets, define and reviewer's guide for multiple studies.
• Provide guidance on resolution of SDTM mapping questions/interpretation.
• Develop computer programs using SAS and performs the necessary manipulations to import external data into SAS or export SAS output to other computer files.
• Develop computer programs, using primarily SAS, to create derived data sets
• Ensure that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines.
• Assist in other programming tasks using software other than SAS to support specialized data analysis requirements.
• Prepare documents to describe SAS programs and databases for large projects
• Perform Quality Control (QC) procedures.
• Assist with the development of computer programs, using primarily SAS, which generate complex listings, tables and complex graphs.
• Assist with database development responsibilities.

Skills And Qualifications

• 8+ years of experience in pharmaceutical industry.
• In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.
• Extensive SDTM mapping and qc experience including independently developing SDTM mapping specs and datasets and e-submission requirements.
• Proficient in SAS programming, including BASE, FSP and SAS macro programming.
• Understanding of SAS database structures and experience with at least one Clinical Database Management System.
• Excellent written, verbal and interpersonal communication skills.
• Regulatory submission programming preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brandon Zheng at (+1) 646-851-0869 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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