Clinical Data Associate

Anavex Life Sciences Corp. is seeking an experienced Clinical Data Programmer. He/She/They will extract clinical data from the clinical data management systems and produces reports, primarily in SAS; and will program reports and listings as requested for ongoing clinical studies. This person will also perform consistency checks on data transferred between outputs and external parties to ensure completeness and accuracy of data transfers.

He/She/They will support Data Management by maintaining a close partnership with the Study Team around applicable study needs in aid of study Database Locks and data deliverables.

Key Responsibilities

* Program SAS Non-System Edit Checks and SAS Data Listings. Converts various external data to SAS datasets.

* Develop independently innovative and complex SAS programs to support clinical data activities including, but not limited to, data review, external data review, and various types of data reporting, including DSURs.

* Manage independently SAS processes and applications while evaluating for improvements.

* Coordinate with Data Managers regarding timelines and deliverables to ensure all SAS programs are working as expected.

* Train Study Team members on how to create and review SAS program specifications, run SAS programs, review SAS logs, and generate outputs.

The position will be filled at a level commensurate with experience with a salary range of $60,000 - $80,000 per year.

Requirements

* Bachelor's degree or higher in a health/healthcare-related field. SAS Certified Base Programmer for SAS 9.4 is highly valued.

* 3-5 years of SAS programming experience in the pharmaceutical or biotechnology industry, depth, and exposure to Data Management related tasks. Understands clinical data structures thoroughly.

* Familiarity with GCP, ICH, and FDA requirements as they apply to clinical data. Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint). Fully conversant in SAS programming and best Clinical Data Management practices. Familiar with SDTM, ADaM, and annotation of eCRFs.

* Strong critical thinking skills. Ability to deliver results and execute required activities individually and in a team setting. Recommends solutions/procedures relating to data programming issues that fall within the boundaries of Anavex policies and procedures as well as the federal regulations and guidelines applicable to the design, conduct, analysis, and reporting of clinical trials. Highly responsive and proactive team player.

Understands the drug development procedures and documents, eCRFs, SAPs, CDISC standards, MedDRA, WHODRUG, Industry SOPs, and Health Authority submission guidelines.

* Proficiency in written and spoken English with excellent written and oral communication skills.

* Ability to work efficiently across multiple projects.

* Should reside in the greater NYC area with the ability to travel to the Manhattan office, as requested.

* Effective in working in a fast-paced start-up environment.