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)