Biostatistician

Founded in 2015, Healthark began as a healthcare and life sciences consulting firm and is rapidly transforming into a tech-first organization specializing in Data Engineering, Data Science, Analytics, Generative AI, and Intelligent Automation.

We are a cross-disciplinary team that fuses deep healthcare domain expertise with cutting-edge technological capabilities to tackle complex, data-driven challenges across the healthcare ecosystem. Our services span Growth and GCC Advisory, Real-World Evidence (RWE), digital health innovation, AI/ML solutioning, and the development of modern data platforms.

With a team of 150+ consultants, data scientists, engineers, and healthcare experts, we have delivered over 1000 high-impact projects across 60+ global markets. Our clientele includes nimble startups as well as global healthcare and life sciences leaders.

From our innovation hubs in Ahmedabad, Bangalore, and Hyderabad, Healthark is driving the next wave of healthcare transformation—leveraging scalable data platforms, automation frameworks, and GenAI-powered insights to deliver measurable outcomes.

Position: Biostatistician

Experience: 6-10 yrs

Location: Hyderabad(Mon-Fri)

Company URL: https://healtharkinsights.com

Position Overview:

We are looking for a skilled and detail-oriented Biostatistician to support Cell and Gene Therapy trials being conducted in India. This role involves developing statistical analysis plans (SAP), conducting interim and final analyses, and ensuring alignment with trial objectives and regulatory requirements. The candidate should have a strong foundation in statistical methodologies, clinical trial regulations, and experience working with multi-disciplinary teams to deliver accurate and meaningful insights from complex clinical data.

Key Responsibilities:

● Develop statistical analysis plans (SAPs) aligned with study protocols and endpoints

● Collaborate with study team during protocol development to define study design and statistical considerations

● Perform sample size estimations and power calculations based on trial objectives

● Conduct interim and final statistical analyses, ensuring accuracy, reproducibility, and compliance with applicable standards

● Generate tables, listings, and figures (TLFs) for clinical study reports and publications

● Perform exploratory data analysis and support signal detection, safety review, and efficacy assessments

● Provide statistical input on data collection and case report form (CRF) design

● Work closely with data management team to resolve data issues and ensure data readiness

● Contribute to interpretation of results and preparation of manuscripts, presentations, and regulatory submissions

Requirements:

● 6–10 years of experience in biostatistics or clinical trial analytics

● Strong knowledge of statistical methods used in clinical trials, including hypothesis testing, survival analysis, mixed models, and longitudinal data analysis

● Proficiency in statistical programming using SAS or R

● Experience in analyzing clinical trial datasets and interpreting results in a regulatory-compliant environment

● Understanding of trial standards and submission requirements

● Familiarity with protocol design, SAP development, and CRF review

● Ability to communicate complex statistical concepts to non-statistical stakeholders

● Strong documentation, reporting, and analytical skills

Skills:

● Familiarity with decentralized or hybrid trial designs

● Experience working with EDC platforms and integrated data environments

● Knowledge of Bayesian methods, adaptive trial designs, or real-world data analysis

● Contributions to peer-reviewed publications or conference presentations

Job Type: Full-time

Pay: ₹500,000.00 - ₹1,700,000.00 per year

Experience:

• Statistical analysis: 5 years (Preferred)

Work Location: In person

Application Deadline: 15/08/2025