Job Title: Associate Director Statistical Programming

DESCRIPTION

Reporting to the Director of Biometrics, the Associate Director of Statistical Programming will be an integral part of the Biometrics group, and will work closely with the Director of Biometrics to provide statistical programming support to data management, regulatory affairs, pharmacovigilance, and all clinical development projects at Cytokinetics as well as to define and maintain various internal programming standards.

RESPONSIBILITIES:
• Group Head of Statistical Programming.
• Responsible for all statistical programming activities, indication or publication activities, and data base structure at Cytokinetics.
• Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for individual studies and ISS/ISE;
• Participate in the review of statistical analysis plans, draft table specifications, design analysis data sets, and provide mapping files for analysis data sets.
• Review, and comment on CRFs, annotated CRFs, and edit checks documents.
• Participate in operations meetings and address issues that may influence statistical programming.
• Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports.
• Perform additional analysis and data validation.
• Cooperate with CRO statistical programmers and validate their work.
• Develop and contribute to Biometrics SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

REQUIREMENTS

• Masters degree in a statistics,
• At least 10 years of biopharmaceutical experience as a Statistical Programmer,
• Five years of supervisory experience,
• Extensive experience in organizing regulatory submissions,
• Extensive experience in BLA, NDA/s NDA submissions.
• Strong leadership skills and team work spirit.

HOW TO APPLY

Please apply online at
http://www.cytokinetics.com/cyto/opportunities/job/CO06-298/apply