Responsibilities

• Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams
• Oversee all the studies for one compound to ensure the consistency of statistical work standards as the project statistical leader
• Responsible for writing statistical methodology section of the protocol, including sample size calculation
• Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE
• Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
• Direct the activities of internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards
• Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents
• Participate in operations meetings, project team meetings, and address issues related to biostatistics
• Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports
• Perform ad hoc analysis and data validation
• Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, statistical programming for TLFs, and data reporting

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• Master’s degree in statistics or biostatistics with 8 years of biopharmaceutical statistics experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry
• Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time
• Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment
• Knowledge of missing data handling, multiple comparisons, and simulation techniques
• Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Strong leadership skills and teamwork spirit
• Experience in the neurology/cardiovascular therapeutic areasdesirable