Director, Biostatistics

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.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

In this exciting role, the Director of Biostatistics will not only have a significant impact on the progress of our late-phase activities, but also the lives of those living with this challenging disease. You will be the lead statistician responsible for the management of a late-stage clinical trial in cardiac myosin activator program. You will also support the development/documentation of procedures and policies for the operations of biostatistics as well as supporting strategic direction.

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.

Qualifications

• Ph.D. in statistics/biostatistics with minimum 8 years of biopharmaceutical statistics experience; Master's degree in statistics or biostatistics with a minimum of 10 years of 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 team work spirit.
• Experience in the neurology/cardiovascular therapeutic areas desirable

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $255,600-$282,500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications
• We will never request personal information such as banking details until after an official offer has been accepted and verified
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• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer