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Full-Time

Director – Biostatistics

Confirmed live in the last 24 hours

Cytokinetics

Cytokinetics

201-500 employees

Develops muscle function drugs for diseases

Biotechnology

Compensation Overview

$198k - $242kAnnually

Senior, Expert

Villanova, PA, USA

Category
Bioinformatics
Computational Biology
Biology & Biotech
Required Skills
Google Cloud Platform
Requirements
  • Master’s degree in statistics or biostatistics
  • 8+ years of biopharmaceutical statistics experience
  • 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
  • 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
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

Cytokinetics is a late-stage biopharmaceutical company focused on developing small molecule muscle activators and inhibitors to address impaired muscle function in conditions such as heart failure, hypertrophic cardiomyopathy, and neuromuscular diseases. The company's main technologies involve engineering drug candidates to impact muscle function and contractility, with the goal of discovering, developing, and commercializing potential treatments for debilitating diseases.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

South San Francisco, California

Founded

1998

Growth & Insights
Headcount

6 month growth

0%

1 year growth

3%

2 year growth

30%