Covance

  • Biostatistician Lead

    Job Location(s) IN-Bangalore | IN-Bangalore
    Job Number
    2018-16960
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Work Location: Bangalore.

     

    The statements below reflect the general responsibilities and requirements of the idetified position but may not describe all the work requirements that may be inherent in the job

     

    • Responsible for development of  Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data-handling rules and mockups.
    • Responsible for Biostatistics deliverables within assigned projects.
    • Perform QC/statistical review of all analysis datasets and data displays.
    • Statistical analysis of clinical trial data and related decision-making
    • Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Covance signatories.
    • Provide statistical representation of multi-disciplinary team preparing protocol; responsible for statistical input; approves as signatory.
    • Provide statistical input into design/review of format of CRFs
    • Supervision of less-experienced biostatisticians within project activities.
    • Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
    • Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
    • Take responsibility for overall status and quality of Biostatistics’ project documentation, including maintenance of hardcopy and electronic files.
    • Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
    • Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listing, statistical reports, Clinical Study Reports.
    • Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
    • Provide support for DMCs, ensuring maintenance of appropriate blinding.
    • SAS programming and related activities for the presentation and analysis of clinical trial data.
    • Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
    • Contact with client across multiple disciplines.
    • Assigned tasks related to the development of less-experienced staff within the department.
    • Contribute to review and amendment of departmental processes and supporting documentation.
    • Contribute to proposals activities and client presentations.
    • Represent the department during project-driven client audits.
    • Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality management System and to GCP.
    • Perform other duties as requested by management.

     

    Top 3 reasons you should join us:

     

    1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.
    2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.
    3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.

     

    Get to know Covance

    Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world.  Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

     

    Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

    • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”
    • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award
    • IMDiversity – Corporate Diversity Honor Roll
    • Flexjobs – Top 100 Remote Work – Company to Watch
    • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”

    To learn more about our exciting opportunities in India, visit www.Covance.com/IndiaCareers

    Education/Qualifications

    Education:

     

    Master’s Degree in Life Sciences (or Pharma/M..Tech/Ph.D) or related health discipline) from an accredited university or college.

    Experience

    • 3 to 5 years of postgraduate experience in the application of statistics to clinical trials for employees with a PHd in statistics subject. 5 to 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
    • Interpersonal and effective communication skills
    • Cooperative, team-oriented and proactive
    • Self motivation
    • The ability to work to tight deadlines while maintaining high standards
    • SAS proficiency including use of a variety of statistical procedures.
    • Ability to adhere to strict guidelines & codes of practice
    • A good knowledge of the overall clinical trial process
    • Experience in the preparation of statistical analysis plans, analysis, reporting etc.
    • Ability to explain statistical concepts to non-statistician
    • Organizational skills
    • An evident appreciation of the possible impact of day to day activities and actions on Covance as a business
    • A professional approach at all times

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