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Biostatistician I

1 - 3 years

0 Lacs

hyderabad telangana india

Posted:1 week ago| Platform: Foundit logo

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Skills Required

sample size estimation powerpoint cdisc inferential statistics ms word adam

Work Mode

On-site

Job Type

Full Time

Job Description

Biostatistician I

Statistician

Biostatistics Manager

Key Responsibilities:

  • Conduct statistical analyses as outlined in

    statistical analysis plans

    , including generating statistical graphics and verifying randomization codes.
  • Prepare statistical sections of

    clinical study protocols

    , including

    sample size calculations

    .
  • Annotate shell data displays and provide specifications for the structure, content, and algorithms of status and analysis datasets.
  • Perform and supervise

    quality control (QC)

    of data displays and inferential statistics.
  • Design, plan, and execute biostatistical components of clinical studies using sound statistical methodology.
  • Develop

    statistical analysis plans (SAPs)

    and reporting specifications.
  • Review and validate

    tables, listings, and figures (TFLs)

    , tabulation datasets, and derived datasets.
  • Analyze and interpret results from clinical studies independently or under guidance.
  • Maintain project documentation and contribute to cross-functional interactions.
  • Utilize advanced computer skills for documentation and reporting using

    MS Word, Excel, PowerPoint

    , and project management tools.

Primary Skills:

  • Statistical Analysis: Sample size estimation, inferential statistics, protocol development
  • Programming: Proficiency in

    SAS

    and clinical data analysis software
  • Data Standards: Familiarity with

    CDISC

    ,

    SDTM

    , and

    ADaM

  • Documentation: Annotated CRFs, SAPs, shell displays, and QC records
  • Communication: Effective verbal and written communication in English

Secondary Skills:

  1. Clinical Research:
    • Understanding of clinical trial methodology and regulatory requirements
  2. Quality Assurance:
    • QC of datasets and statistical outputs
  3. Collaboration:
    • Cross-functional teamwork and stakeholder engagement
  4. Project Organization:
    • File management and audit readiness
  5. Mentorship:
    • Support and guidance for junior team members

Preferred Qualifications:

  1. Master's degree in

    Statistics

    or related field
  2. Minimum

    3 years of experience

    as a Statistician for Senior level minimum

    1 year

    or EDETEK training and supervisory approval for non-Senior level
  3. Proficiency in

    SAS

    and similar clinical data analysis tools
  4. Experience in preparing statistical components of protocols and SAPs
  5. Strong analytical and organizational skill
Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

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