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: Clinical Research Medical Writer Experience: 6 to 10 yrs Location: Hyderabad (Mon-Fri) Company URL: https://healtharkinsights.com Position Overview: We are seeking an experienced and detail-oriented Clinical Research Medical Writer to support the design and development of clinical trials, trial documentation and scientific communication for Cell and Gene Therapy clinical trials and other advanced therapy studies being conducted in India. The candidate will be responsible for drafting protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports (CSRs) for both Indian and global studies, while also contributing to scientific publications and other study deliverables as needed. Key Responsibilities ● Draft and revise Study Design, Clinical Trial Protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Clinical Study Reports (CSRs), and Investigator Brochures (IBs) in accordance with ICH-GCP guidelines and other regulatory requirements (e.g., CDSCO, ICMR, FDA, EMA) ● Develop content for scientific abstracts, posters, and manuscripts for peer-reviewed journals and international conferences. ● Conduct literature reviews and summarize key findings relevant to ongoing and upcoming studies. ● Reviewing Statistical Analysis Plans (SAPs) to ensure alignment with study objectives, protocols, and regulatory requirements ● Review and interpret statistical outputs to accurately present efficacy and safety data in clinical documents ● Assist in the preparation of responses to regulatory bodies or ethics committees as needed. ● Support regulatory writer for preparing documentation required for regulatory submissions ● Ensure all documents meet internal quality standards and adhere to regulatory, journal, and company guidelines. ● Collaborate with clinical, data management, regulatory, and quality teams to ensure alignment on study deliverables. ● Collaborate with the Germany team and support global clinical trials and documentation efforts ● Maintain high standards of scientific integrity, accuracy, and compliance in all documentation. ● Track document timelines and ensure timely submissions across deliverables. Requirements: ● Master’s degree or equivalent in Life Sciences, Clinical Research, Public Health, Epidemiology, Pharmacy, or related field. ● Minimum 6-10 years of experience in study design and clinical trial documentation within the pharmaceutical, CRO or clinical research setting. ● Prior experience in drafting clinical trial documents and publishing in peer-reviewed journals is essential. ● Must have proven experience in authoring scientific publications in reputable journals, as well as contributing to scientific abstracts presented at renowned international conferences. ● Must have experience in preparing figures and graphs for scientific publications and conference abstracts. ● Proficiency in statistical analysis, with a preferred background in epidemiology or biostatistics Skills: ● Excellent written and verbal communication skills ● Familiarity with data analytics tools, including PowerPoint, GraphPad Prism, SPSS, and Adobe software. ● Ability to review and comprehend research papers and provide concise literature summaries to the senior team. ● Ability to manage multiple projects simultaneously and adapt to evolving priorities. ● Comfortable working independently and in cross-functional teams. Job Type: Full-time Pay: ₹300,000.00 - ₹1,000,000.00 per year Education: Master's (Preferred) Experience: medical writing: 6 years (Required) Location: Hyderabad, Telangana (Required) Work Location: In person
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
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