Associate Director*, Statistical Programming

Cytokinetics, Incorporated South San Francisco , CA 94080

Posted 2 months ago

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-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.

We are currently seeking an Associate Director of Statistical Programming to become a part of the growing Clinical Biometrics organization which is comprised of Biostatistics, Statistical Programming, and Clinical Data Management groups.

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 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.

Qualifications

  • Bachelor's or Master's degree in biostatistics, computer science, or related fields, Master's degree preferred;

  • At least 12 years of biopharmaceutical experience as a Lead Statistical Programmer in the biotech or 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.

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

  • Title commensurate with experience
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Associate Director*, Statistical Programming

Cytokinetics, Incorporated