Biostatistician I

3 days ago


Hyderabad, Telangana, India Capgemini Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Biostatistician I
Job Description:

We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards.

Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment.


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.

  • Senior Statistician I

    2 weeks ago


    Hyderabad, Telangana, India Capgemini Full time ₹ 12,00,000 - ₹ 18,00,000 per year

    Your RoleWe are seeking an experienced and collaborative Senior Statistician I to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory...


  • Hyderabad, Telangana, India Medpace Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Medpace, a rapidly growing global Clinical Research Organization (CRO), is excited to announce that we're looking for experienced full-time, Hyderabad-based Biostatistician to join us as we prepare to launch of our newest office inHyderabad, India.This is more than just a job. It's an opportunity to be part of something from the very beginning. You'll play a...

  • Biostatistician I

    2 weeks ago


    Hyderabad, India Jobted IN C2 Full time

    Biostatistician I Job Description: We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the...

  • Biostatistician I

    2 weeks ago


    Hyderabad, India Capgemini Full time

    Biostatistician I *About The Role : We are seeking a skilled and detail-oriented Statistician * to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the...

  • Senior Statistician I

    2 weeks ago


    Hyderabad, India Capgemini Full time

    Your Role We are seeking an experienced and collaborative Senior Statistician I to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory...


  • Hyderabad, India Medpace Full time

    Medpace, a rapidly growing global Clinical Research Organization (CRO), is excited to announce that we're looking for experienced full-time, Hyderabad-based Biostatistician to join us as we prepare to launch of our newest office inHyderabad, India. This is more than just a job. It's an opportunity to be part of something from the very beginning. You'll play...


  • Hyderabad, India Jobted IN C2 Full time

    Job Summary : Medpace, a rapidly growing global Clinical Research Organization (CRO), is excited to announce that we’re looking for experienced full-time, Hyderabad-based Biostatistician to join us as we prepare to launch of our newest office in Hyderabad, India. This is more than just a job. It’s an opportunity to be part of something from the very...

  • Senior Statistician I

    2 weeks ago


    Hyderabad, India Jobted IN C2 Full time

    Job Description: We are seeking an experienced and collaborative Senior Statistician to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory...


  • Hyderabad, India MEDPACE Full time

    Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage...

  • Clinical Programmer

    1 week ago


    Hyderabad, Telangana, India Clinotica Full time

    **JOB SUMMARY This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct statistical analysis and reporting of projects. A Statistical Programmer I creates, tests and maintains programs for clinical studies, under the...