Responsibilities:
• Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams • 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.. • Review, and comment on CRFs, annotated CRFs, and edit checks documents. • Participate in operations meetings and address issues related to biostatistics. • Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports (including review and comment on draft version of TLFs). • Perform additional analysis and data validation. • Develop and contribute to Biometrics SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.
NOTES: Employer will assist with relocation costs
Requirements
Qualifications: • Masters degree in biostatistics with a minimum of 8 years experience 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 in a regulated clinical research environment • Experience in organizing regulatory submissions, • Experience in BLA, NDA/s NDA submissions. • Strong leadership skills and team work spirit. • Experience in the oncology/cardiovascular therapeutic area.
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.
Please visit our website at: www.cytokinetics.com. Cytokinetics is an Equal Opportunity Employer.
About Cytokinetics, Inc.
Cytokinetics, Inc. is a leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. A number of commonly used drugs and a growing body of research validate the role that the cytoskeleton plays in a wide array of human diseases. Our focus on the cytoskeleton enables us to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease and other diseases.
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