Senior SAS Programmer Analyst

This position is 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.

• 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.

• Good communication skills with strong verbal, written and interpersonal communication skills.

• Strong organizational skills with ability to effectively manage multiple projects.

• Strong teamwork ability/commitment and individual initiative.

• Proven experience with UNIX and Windows operating systems.

• Understanding of the software development life cycle.

• Understanding of FDA guidelines.

• Good organization, time management and attention to detail skills.

• Needed to work in a stressful environment under tight deadlines while.

• Maintaining focus on details and quality.

• Applies good judgment and demonstrates initiative to resolve issues.

Thanks!!

With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x 219

Inc. 5000 – 2007-2015 (9 Years in a row)