Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

job Description

• The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products.
• The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity.
• The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.

Responsibilities:

• Leads the statistical programming activities for projects with lower complexity.
• Leads the statistical programming activities for studies.
• Develop SAS programs for the creation of ADaM data sets following
  CDISC standards.
• Develop SAS programs for the creation of Tables, Listings and Figures.
• Validation of ADaM data sets, Tables, Listings and Figures.
• Create specifications for the structure of ADaM data sets for individual studies and integrated data.
• Create documentation for regulatory filings including reviewer's guides and data definition documents
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

Requirements:

• MS in Statistics, Computer Science or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• Fundamental understanding of CDISC Standards.
• Fundamental understanding of the drug development process, including experience with regulatory filings.
• Ability to communicate clearly both oral and written.
• Ability to accurately estimate effort required for study related programming activities.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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