Job Description

W2 Candidates only !!

Woodcliff Lake NJ, 07677 - This can be 100% remote. They need to work in the EST, and be 100% in the US.

***Need strong submission experience and someone who is able to work independently. ***

Qualifications and education required:
• MS in Biostatistics/Statistics preferred, with at least 7 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.

Support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate and QC outputs; and ensure timely and accurate programming and validation activities for clinical studies and publications. Review abstract/manuscripts (publication) to ensure accuracy, quality and soundness of statistical methodologies, and overseeing external vendors as required.

Will also Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables and work on submission teams as a statistician and/or a programmer.

Additional Information

All your information will be kept confidential according to EEO guidelines.