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Capgemini
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Biostatistician II

Biostatistician II

Capgemini

3 - 8 years

7 - 12 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

adam data analysis sas clinical data sdtm data management regulatory documentation project documentation regulatory compliance protocol development qc clinical research quality assurance cdisc software engineering statistical programming statistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

About The Role :
We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming.
Key Responsibilities:

Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans.

Design and verify randomization codes to ensure clinical trial integrity.

Prepare statistical sections of protocols, including sample size calculations and annotated shell data displays.

Provide specifications for the structure, content, and algorithms of status and analysis datasets.

Perform and oversee quality control (QC) of data displays and datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM).

Conduct independent validation of datasets created by other programmers or statisticians.

Maintain project documentation including protocols, annotated CRFs, SAPs, and programming/QC records.

Organize and manage electronic project directories to ensure accessibility and version control.

Mentor junior programmers and provide training on SAS programming and clinical data standards.

Primary
Skills:

Statistical ProgrammingProficiency in SAS for clinical data analysis

Clinical ResearchUnderstanding of clinical trial design , randomization, and statistical methodology

Data StandardsFamiliarity with CDISC , SDTM , and ADaM

Quality AssuranceExperience in QC processes and dataset validation

DocumentationAbility to create and maintain technical and regulatory documentation

Secondary
Skills:

Statistical Analysis:

Sample size estimation, inferential statistics, protocol development

Data Management:

Annotated CRFs, dataset specifications, metadata handling

Communication:

Clear documentation and collaboration with cross-functional teams

Mentorship:

Training and guiding junior staff in programming and standards

Project Organization:

File management, version control, and audit readiness

Preferred Qualifications:

Masters degree in Statistics or related field (or Bachelors with equivalent experience)

Minimum 3 years of experience as a Biostatistician in the clinical research industry

Proficiency in SAS and clinical data analysis software

Experience with CDISC standards and regulatory compliance

Prior experience in mentoring or training junior team members

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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Biostatistician II