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Capgemini
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Biostatistician II

Biostatistician II

Capgemini

3 - 5 years

0 Lacs

hyderabad telangana india

Posted:1 week ago| Platform: Foundit logo

Apply

Skills Required

documentation clinical trial design cdisc statistical programming quality control adam

Work Mode

On-site

Job Type

Full Time

Job Description

Biostatistician II

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 Programming: Proficiency in
SAS
for clinical data analysis
Clinical Research: Understanding of
clinical trial design
, randomization, and statistical methodology
Data Standards: Familiarity with
CDISC
,
SDTM
, and
ADaM
Quality Assurance: Experience in
QC processes
and dataset validation
Documentation: Ability 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:

Master's degree in Statistics or related field (or Bachelor's 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

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Biostatistician II

Key Responsibilities:

SAS programs

randomization codes

sample size calculations

structure, content, and algorithms

quality control (QC)

CDISC standards

independent validation

electronic project directories

SAS programming

Primary Skills:

SAS

clinical trial design

CDISC

SDTM

ADaM

QC processes

Secondary Skills:

Preferred Qualifications:

SAS

CDISC standards

More Jobs at Capgemini