This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Biostatistician based in the India.
The Senior Biostatistician will provide strategic statistical leadership and technical expertise supporting oncology clinical trials across multiple development phases. This role plays a key part in study design, statistical analysis planning, data interpretation, and regulatory reporting activities. Working within a collaborative clinical research environment, the position partners with sponsors and cross-functional teams to deliver high-quality statistical solutions. The ideal candidate will bring strong oncology trial experience, CRO expertise, and the ability to communicate complex statistical concepts effectively. This is an opportunity to contribute to impactful clinical programs while supporting innovative therapies and rigorous scientific decision-making. The role offers exposure to global studies, regulatory processes, and multidisciplinary collaboration.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Biostatistician based in the India.
The Senior Biostatistician will provide strategic statistical leadership and technical expertise supporting oncology clinical trials across multiple development phases. This role plays a key part in study design, statistical analysis planning, data interpretation, and regulatory reporting activities. Working within a collaborative clinical research environment, the position partners with sponsors and cross-functional teams to deliver high-quality statistical solutions. The ideal candidate will bring strong oncology trial experience, CRO expertise, and the ability to communicate complex statistical concepts effectively. This is an opportunity to contribute to impactful clinical programs while supporting innovative therapies and rigorous scientific decision-making. The role offers exposure to global studies, regulatory processes, and multidisciplinary collaboration.
Accountabilities:
- Provide statistical support for clinical trials from study initiation through final reporting and regulatory submission.
- Contribute to study design, sample size calculations, endpoint selection, randomization strategies, and statistical analysis approaches.
- Develop and review protocols, statistical analysis plans (SAPs), mock shells, and other statistical documentation.
- Collaborate with sponsors, clinical operations, data management, statistical programming, medical writing, and regulatory teams.
- Review statistical outputs, including tables, listings, and figures, to ensure accuracy, quality, and consistency.
- Support interim analyses, safety reviews, efficacy assessments, and final clinical study reporting.
- Review ADaM specifications, derived endpoints, and analysis datasets.
- Support Data Monitoring Committee (DMC/IDMC) activities, including preparation and review of analysis outputs, safety summaries, and meeting materials.
- Interpret statistical results and communicate insights clearly to internal stakeholders and external partners.
- Ensure deliverables meet timelines, SOP requirements, regulatory expectations, and quality standards.
- Support responses to sponsor inquiries, audits, and health authority questions related to statistical activities.
- Mentor junior statisticians and contribute to process improvements and best practices.
- Contribute to proposals, bid preparation, and project planning activities when required.
- Support oncology-specific analyses, including time-to-event endpoints, subgroup analyses, sensitivity analyses, and response criteria such as RECIST and iRECIST.
- Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative discipline.
- Typically 5–8+ years of biostatistics experience within clinical research, pharmaceutical, biotechnology, or CRO environments.
- Strong preference for candidates with CRO experience.
- Experience supporting oncology clinical trials and DMC/IDMC activities is highly preferred.
- Strong knowledge of clinical trial statistical methodologies, including survival analysis, categorical data analysis, and longitudinal data analysis.
- Understanding of ICH, GCP, and relevant regulatory requirements.
- Experience authoring or reviewing SAPs, protocols, statistical outputs, and study documentation.
- Familiarity with CDISC standards, including SDTM and ADaM.
- Proficiency in SAS is required; experience with R is a plus.
- Ability to support global clinical trials and regulatory submissions.
- Strong written and verbal communication skills with the ability to engage effectively with sponsors and cross-functional teams.
- Ability to manage multiple priorities while maintaining high-quality deliverables.
- Experience mentoring or training colleagues is an advantage.
- Remote work flexibility.
- Comprehensive medical, dental, and vision insurance options for eligible employees.
- Paid vacation time and sick leave.
- Annual corporate holidays.
- Participation in a 401(k) retirement plan for eligible U.S. employees.
- Access to employee assistance programs and wellness resources.
- Health advocacy services.
- Employee discounts and perks across areas such as fitness, insurance, retail, entertainment, pets, and more.
- Opportunity to contribute to impactful oncology research within a collaborative global environment.
The Senior Biostatistician will be responsible for providing statistical guidance throughout the full clinical trial lifecycle, ensuring accurate, timely, and compliant delivery of study-related statistical activities.
Requirements:
The ideal candidate will have a strong foundation in biostatistics, clinical research methodology, and oncology trial support, with the ability to manage complex studies in a fast-paced environment.
Benefits:
Benefits may vary depending on location, with competitive offerings available based on country-specific requirements.