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SAS Programmer Analyst / Biostatistician

Woodcliff Lake, New Jersey, United States
April 05, 2018

Responsible for supporting the phase 3 clinical trial, including but not limited to, as outlined below:

• Reviews SAP, TLG shells and variable derivation rules and provides feedback Develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data.

• Develops the Data Monitoring Committee charter in collaboration with other functions and liaises with independent statisticians Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific dataset specs.

• Performs and validates statistical analysis Independently reviews CSRs and performs data interpretation Supports submission strategy planning, regulatory communication and development of Health Authorities responses.

• Creates/ validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)

Job Requirements:

• MS in Biostatistics/Statistics preferred, with at least 5 years of experience in the pharmaceutical, CRO or biotech industry.

• Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH.

• Strong CDISC data standards, e.g. SDTM and ADaM Good technical writing skills.

• Proven experience with UNIX and Windows operating systems. Understanding of the software development life cycle. Understanding of FDA guidelines.