Bioinformatics Analyst

Title:

Bioinformatics Analyst
Company: SS Innovations Private Limited

Location:

Udyog Vihar, Phase-III, Gurgaon, Haryana Employment
Type:
Full Time Relevant

Experience:

10+ Year’s
Salary:
As per the Industry Standard
Reporting to - CEO (APAC)

Position Summary:

The Bioinformatics Analyst will lead and execute statistical activities for clinical trials, contributing to study design, protocol development, randomization, and statistical analysis. The role involves generating high-quality analysis datasets and outputs (TLFs) using SAS and/or R, interpreting results, ensuring regulatory compliance, and mentoring junior statisticians.

Study Design & Protocol Development
-Develop and review statistical sections of clinical trial protocols.
-Perform sample size calculations, define endpoints, and design randomization schemes.
Statistical Analysis & Reporting
-Author Statistical Analysis Plans (SAPs).
-Create derived datasets and generate Tables, Listings, and Figures (TLFs).
-Interpret statistical results and contribute to clinical study reports.
Quality Control & Compliance
-Validate statistical programs and datasets developed by team members.
-Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines.
Leadership & Cross-Functional Collaboration
-Act as the primary statistical point of contact for internal teams, clients, and CRO partners.
-Provide technical guidance and mentorship to junior statisticians.
Regulatory & Safety Support
-Support Data Monitoring Committees (DMC/DSMB) activities.
-Assist in responding to regulatory authority queries and inspections.

Required Qualifications & Skills
Education
-Master’s or PhD in Statistics, Biostatistics, or a related discipline.
Experience
-10 + years  of industry experience in biotechnology, or CRO environments.
Programming & Tools
-Strong proficiency in  SAS  (BASE, STAT, GRAPH).
-Working knowledge of  R  is highly desirable.
Technical Expertise
-Solid understanding of clinical trial methodologies and statistical principles.
-In-depth knowledge of regulatory standards and guidelines (ICH-GCP, CDISC).
Soft Skills
-Strong leadership, mentoring, and project management capabilities.
Excellent written and verbal communication skills.

Note:

Interested candidates are encouraged to email their updated resumes directly to “jobs. Please refrain from sending direct messages or personally approaching our Senior Management Team. Such actions will not be entertained and could be seen as a breach of professional conduct. The violation could negatively impact your chances of future employment with us as it does not align with professional conduct and etiquette.

Thanks, HR Department