Biostatistical Expert

3 weeks ago


Hyderabad, Telangana, India Parexel Full time

Key Responsibilities

  • Provide statistical support for trial design, protocol, and CRF development.
  • Lead production and quality control of randomization, analysis plans, statistical reports, and other process supporting documents.
  • Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols.
  • Provide statistical input into Data Monitoring Committee (DMC) activities, including DMC charters and analysis plans.

General Activities

  • Understand regulatory requirements related to therapeutic areas and statistical processing and analysis implications.
  • Understand and apply advanced statistical methods.
  • Contribute to internal and external statistical training seminars and courses.
  • Review position papers based on current good statistical practice.
  • Interact with clients and regulatory authorities.

Requirements

  • PhD or MS in Statistics or related discipline with substantial experience.
  • Competent in written and oral English.


  • Hyderabad, Telangana, India Parexel Full time

    Unlocking the Power of BiostatisticsThe Senior Biostatistical Expert will lead the development of statistical methodologies and analysis plans for complex clinical trials, ensuring compliance with regulatory requirements and delivering high-quality results.Key Responsibilities:Design and implement statistical analysis plans for clinical trialsDevelop and...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. As a Biostatistics Expert with a focus on regulatory requirements, you will play a crucial role in shaping the future of drug development and delivery.Salary: $120,000 - $180,000 per yearAbout the...


  • Hyderabad, Telangana, India Parexel Full time

    About the RoleThe Senior Biostatistical Expert will provide high-level statistical support across all complexity levels of clinical trials, with a strong focus on regulatory impact.Key ResponsibilitiesDevelop and implement trial designs, protocols, and CRF configurations.Lead the production and quality control of randomization, analysis plans, statistical...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job Description for Associate Director Statistical ProgrammingBristol Myers Squibb is seeking an exceptional Associate Director to lead our Statistical Programming team in the development, regulatory approval, and market acceptance of our innovative products.Key Responsibilities:Design, develop, and implement technical solutions for integrating, analyzing,...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    About This RoleThis position serves as a key functional expert and leader to clinical project teams to drive the development, regulatory approval, and market acceptance of Bristol Myers Squibb products.Key ResponsibilitiesDesign, develop, and implement technical solutions for integrating, analyzing, and reporting clinical data.Drive the development and...


  • Hyderabad, Telangana, India Parexel Full time

    Unlock your potential in a dynamic environment where collaboration and innovation thrive.About the Role:We are seeking a highly skilled Clinical Data Analyst II to join our team of experts in statistical programming. As a key member of our team, you will be responsible for analyzing and interpreting clinical study data, as well as developing and maintaining...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Company OverviewBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science.Our vision is to be the global biopharma leader in discovering, developing, and delivering innovative medicines that help patients achieve their best possible health outcomes.


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryBristol Myers Squibb is seeking a Senior Manager, Statistical Programming to provide comprehensive programming expertise to clinical project teams. This role is responsible for leading statistical programming teams and supporting the development, regulatory approval, and market acceptance of Bristol Myers Squibb products.Key...


  • Hyderabad, Telangana, India K3-Innovations, Inc. Full time

    About the RoleK3-Innovations, Inc. is seeking a skilled Senior Statistical Programmer to join our team in a critical role that combines programming expertise with business acumen.Job Description:We are looking for a highly motivated and detail-oriented individual with a strong background in statistical programming and data management.The successful candidate...

  • Expert Data Science

    5 months ago


    Hyderabad, Telangana, India Novartis Full time

    **Summary**: As a Expert Data Science you need to Understands business problems, supports integrated analytical approach to mine data sources, manage data effectively, employ statistical methods and machine learning algorithms to contribute solving unmet medical needs, discover actionable insights and automate process for reducing effort and time for...


  • Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Picture Yourself At Parexel: The Biometrics Delivery Lead (DL), reporting into the Global Biometrics Account Lead (AL) has overall accountability for the execution of the Data Operations strategy and the Data Operations technology set up for the EMEA project. The DL provides overall...