Job Description

Job Number: 19-09899
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Statistician for our client in Madison, NJ.

Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Required Qualifications:
  • Strong knowledge in the SAS statistical analysis system
  • Excellent knowledge of statistical methodology and a working knowledge of computer systems
  • Ability to explain statistical information to non-statisticians
  • Knowledge of regulatory requirements governing clinical research
  • Able to identify appropriate statistical methods for common scenarios that arise
  • Independently delivers outputs to agreed quality and milestones
Preferred Qualifications:
  • Knowledge of other statistical analysis systems 

  • PhD (Statistics of Biostatistics) – 3 years; or MS (Statistics or Biostatistics) > 5 years

  • Provides statistical support for protocol development, statistical analysis plan (SAP), statistical analysis, study reporting and publications as needed
  • Ensures that the study design is appropriate, and that appropriate statistical methodologies are used
  • Supports consumer behavior studies, submission related statistical activities, or periodic safety update as needed
  • Provides statistical expertise to develop and champion techniques intended to increase understanding of drug development problems and seeks creative solutions by pursuing active research through collaborations and interactions with other colleagues
  • In partnership with statistical leadership, establishes sound statistical bases for the design and analysis of studies and provides clear guidance to project or program teams for execution
  • Ensures biostatistics-related activities conducted by the study teams and Contract Research Organizations (CROs) are consistent with defined procedures, Pharmaceutical SOPs, as well as industry guidelines and standards
  • Utilizes statistical knowledge and expertise to provide statistical support for clinical studies and publications
  • Participates in protocol and SAP development and ensures appropriateness of study design, sample size and statistical methodologies
  • Provides randomization specifications, including reviewing mock randomization listings against the study design and protocol requirements per SOPs
  • Participates in the process of CRF design and development, ensuring that it meets the protocol criteria and captures all data required to support the planned analysis
  • Reviews edit check specifications by making sure that key variables are validated properly
  • Specifies the structure of the datasets that will be delivered for statistical analysis, making sure that the structure follows existing company standards
  • Reviews, and approves tables, listings and graphs specifications
  • Actively participates in project/study team meetings
  • Establishes/negotiates timelines for completion of study related statistical activities, and ensures the study timelines are met
  • Performs/reviews statistical analysis, interprets analyses results, and reviews the corresponding sections of the clinical study report (CSR)
  • Oversees the generation of all statistical appendices
  • Reviews other sections of the CSR as appropriate
  • Generates SAP for pooling studies for regulatory submissions and executes them, ensuring that accurate statistical methods are used in the analyses
  • Assists with writing and reviewing statistical sections of integrated summary reports
  • Interacts with the FDA on statistical matters as needed
  • Plans and coordinates interim analyses, as needed
  • Provides oversight of biostatistics related activities for studies subcontracted to a CRO or a vendor as needed:
    • Ensures that tasks are being performed according to the appropriate SOPs and in accordance with GCP
    • Oversees the CRO's work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate
    • Clarifies and communicates expectations for statistical deliverables
    • Performs quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP
  • Reports to Lead, Biostatistics and Analysis, PCH
  • Collaborates with programming, data management, clinical research, clinical operations, medical affairs, safety, and regulatory affairs representatives, as well as global franchise teams 

If hired, you will enjoy the following Eclaro Benefits:
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
Jane Bautista
Jane Bautista | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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