Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
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 areas desirable
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
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.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer