Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or deteriorating. With an unmatched understanding of muscle biology and mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Working collaboratively, Cytokinetics? dedicated employees are focused on advancing novel mechanism therapeutics to dramatically improve the lives of patients. With purpose and passion, we have committed to making an important impact on serious medical illnesses.
We are currently seeking, a motivated Statistical Programmer to become a part of the growing Clinical Biometrics organization which is comprised of Biostatistics, Statistical Programming, and Clinical Data Management groups.
The Statistical Programmer will interact with Statisticians, Clinical Data Managers, Clinical Trial Project Managers, and other personnel to provide programming support for clinical studies and ad hoc analyses
Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses
Provide programming support to clinical data management including identifying, reporting, and resolving raw data issues
Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
Review CRFs, annotated CRFs, and edit checks documents.
Participate in study team meetings and address issues that may affect statistical programming.
Support and participate in the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports.
Perform ad hoc analyses 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.
Bachelor degree in biostatistics, computer science, or comparable with demonstrated technical ability, with a minimum of 5 years experience as a Statistical Programmer in the pharmaceutical industry.
The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Proficient of SAS programming in a regulated clinical research environment
Experience of leading late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
Experience in BLA, NDA/sNDA and EMA submissions.
Strong leadership skills and team work spirit.
Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.