Clinical Programmer

SENIOR CLINICAL PROGRAMMER

12+ MONTHS RENEWABLE

SUMMARY:

A global pharmaceutical company in the Bay area needs the support of an experienced Clinical Programmer for their team.

ROLE & RESPONSIBILITIES

• Creation of SAS programs to manage the import/export of data from the clinical database.
• Development and maintenance of programs to import external and internal data files.
• Provide programming support to generate listings to detect data quality issues for the study teams.
• Generation of reconciliation listings cross systems to ensure data consistency and accuracy for the study team.
• Provide support to the data manager in the review of Data Transfer Specifications for accuracy and provide lab codes to enable standardization.
• Communicate and collaborate with the study team to identify and provide support to resolve data issues, and ensure data quality and consistency.
• Creation of SAS programs to manage datasets required for data snapshots and database lock deliverables.
• Creation and maintenance of data visualization in Spotfire.
• Creation and management of the operational datasets on the central servers (i.e. enable blinding/un-blinding, masking/unmasking, merging of datasets, etc.)
• Manage the processing of data files on an sFTP server platform.
• Other services as required.

QUALIFICATIONS & REQUIREMENTS

• 5-8+ years of expertise working in SAS programming.
• Must have Unix experience, in addition to other programming languages such as Unix shell script, PERL, PHP, or Python.
• Bachelor's Degree, preferably in Computer Science, Mathematics or other related scientific discipline; Or, completion of a certified relational database training program/course work or related web development program/course work, and six years (total) of relevant experience in data management and system validation.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
• Strong interpersonal skills with demonstrated capability of working on multiple projects simultaneously.

LOCATION:

California based company. Pacific hours overlap is required.