Associate Director, Statistical Programming
Company Name:-
Cytokinetics
Job Location:-
South San Francisco, CA 94080
Job Summary:-
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing next-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.
As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
We take a purpose-driven approach by leveraging our unique muscle biology expertise to engineer compounds with specific characteristics aimed at treating diseases that impact muscle function, like heart failure, hypertrophic cardiomyopathy, ALS and SMA.
We view our employees as the unequivocal ingredients to success.
Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives.
While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded.
We seek exceptional individuals to join us in our mission to develop potential medicines to improve the healthspan of people with cardiovascular and neuromuscular diseases of impaired muscle function.
Responsibilities
The Associate Director of Statistical Programming 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, and comment on CRFs, annotated CRFs, and edit checks and related 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 a
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