1,717 Lead Statistician jobs in India

The Senior Biostatistician plays a pivotal role in driving the success of clinical trials by leading and developing statistical strategies and deliverables.

This position contributes to the planning, execution, and interpretation of statistical analyses ensuring high-quality, timely deliverables that meet regulatory requirements.

Key Responsibilities:

• Serves as biostatistics leader for assigned studies and projects, providing strategic guidance and oversight.
• Leads or contributes to study design discussions, ensuring alignment with project goals and objectives.
• Authors and reviews Statistical Analysis Plans (SAPs), guaranteeing accuracy and compliance.
• Oversees and ensures the execution of statistical analyses per SAP in collaboration with programming and CRO partners.
• Provides statistical leadership in vendor oversight, maintaining quality and integrity.
• Regularly communicates project status to management, ensuring transparency and accountability.
• Provides statistical input and review for clinical study reports, regulatory documents, and publications.
• Performs quality control (QC) of statistical outputs, identifying areas for improvement.
• Leads or supports regulatory interactions on statistical issues, ensuring compliance and resolution.
• Delivers statistical presentations to internal and external stakeholders, effectively communicating results.
• Contributes to the development, review, and maintenance of statistical standard operating procedures, promoting efficiency and consistency.

Requirements:

• Master's degree or PhD in Biostatistics, Statistics or related quantitative field, with a strong academic background.
• Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates, with a proven track record of success.
• Proficiency in statistical programming in SAS, with expertise in data analysis and modeling.
• Solid knowledge of statistical methodologies and clinical trial designs, with a deep understanding of research principles.
• Strong understanding of CDISC standards, with experience in data submission and reporting.

Senior Biostatistician Opportunity

We are seeking an experienced Senior Biostatistician to lead and oversee statistical strategies for clinical trials. As a key member of our team, you will contribute to planning, execution, and interpretation of statistical analyses across development programs.

This role is responsible for:

• Biostatistics leadership for assigned studies
• Study design discussions, including protocol development and endpoint definition
• Authoring Statistical Analysis Plans (SAPs) and reviewing mock tables and figures
• Overseeing statistical programming activities and managing deliverables
• Regular communication of project status to management
• Providing statistical input for clinical study reports and publications
• Performing quality control (QC) of statistical outputs
• Delivering statistical presentations to stakeholders

To be successful in this role, you will need:

• A Master's degree or PhD in Biostatistics, Statistics, or a related field
• 8+ years of experience in clinical trial biostatistics
• Proficiency in statistical programming in SAS
• Solid knowledge of statistical methodologies and CDISC standards

Key Responsibilities:

• The Senior Biostatistician plays a pivotal role in driving statistical strategies and deliverables for clinical trials. This entails contributing to study design, authoring statistical analysis plans, and overseeing vendor oversight.

Essential Functions:

• Serves as the biostatistics leader for assigned studies
• Leads or contributes to study design discussions, including protocol development and sample size estimation
• Authors and reviews statistical analysis plans, including mock tables and figures
• Oversees the execution of statistical analyses in collaboration with programming and cRO partners
• Communicates project status to management and escalates issues or risks timely

Required Qualifications:

• Masters degree or PhD in Biostatistics, Statistics, or related quantitative field
• Minimum 8 years experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates
• Proficiency in statistical programming in SAS, with knowledge of R and other programming languages preferred

Desirable Qualifications:

• Solid knowledge of statistical methodologies and clinical trial designs
• Strong understanding of CDISC standards, such as SDTM and ADAM
• Experience providing statistical oversight of vendors and managing cRO collaborations
• Proven ability to manage multiple studies concurrently

Senior Biostatistician Job Summary

A lead statistician is sought to join our team. The position entails collaborating with clinical investigators to design studies, contributing to protocol development, and authoring statistical analysis plans.

Key Responsibilities

• Team Leadership : Supervise a team of biostatisticians, associate biostatisticians, and SAS programmers to direct their work on clinical research studies.
• Statistical Consultation : Provide expert consultation to projects across the company on statistical methodology, including solving complex problems and reviewing proposed statistical designs.
• Professional Development : Stay current with statistical and medical literature, enhance current statistical knowledge and practices through innovation, and participate in statistical process development and improvement.
• Communication : Present at statistical conferences, support client research projects with strategic, scientific, and statistical input, and represent the organization at regulatory meetings.
• Leadership : Lead project teams' development of study analysis plans and statistical programs, perform sample size calculation, and provide leadership in statistical design.
• Quality Assurance : Review protocols and case report forms to ensure standards are maintained and develop study assignment allocation schemas.

About the Role

This role requires strong leadership and communication skills, as well as expertise in statistical methodology and data analysis. The ideal candidate will have experience working in a clinical research environment and be familiar with industry-standard software and tools.

The Senior Biostatistician is a key role responsible for leading statistical strategies and deliverables in support of clinical trials.

• Biostatistics leader for assigned studies and projects
• Study design discussions, including protocol development, endpoint definition, and sample size estimation
• Author and review Statistical Analysis Plans (SAPs)
• Oversee statistical analyses per SAP in collaboration with programming and CRO partners
• Vendor oversight, including directing statistical programming activities and managing deliverables
• Statistical leadership in regulatory interactions on statistical issues
• Deliver statistical presentations to internal and external stakeholders

To be successful in this role, you will need:

• A Master's degree or PhD in Biostatistics, Statistics or related quantitative field
• 8 years of experience in clinical trial biostatistics for MS-level candidates; 6 years for PhD-level candidates
• Proficiency in statistical programming in SAS, knowledge of R and other programming languages preferred
• Solid knowledge of statistical methodologies and clinical trial designs
• Experience with regulatory support and interaction
• Proven ability to manage multiple studies concurrently
• Excellent verbal and written communication skills

Senior Biostatistician Role Overview

The Senior Biostatistician plays a pivotal role in developing and executing statistical strategies for sponsored clinical trials. Working under the guidance of the Head of Biostatistics, this position contributes to the planning, execution, and interpretation of statistical analyses across various development programs.

The role of Senior Biostatistician is a leadership position that involves driving statistical strategies and deliverables for clinical trials. The individual in this role will contribute to planning, execution, and interpretation of statistical analyses across various development programs.

• Leads study design discussions including protocol development and endpoint definition to ensure the successful delivery of clinical trials.
• Authors and reviews Statistical Analysis Plans (SAPs), mock tables, figures, and listings (TFLs) to ensure accuracy and compliance with internal standards.
• Oversees the execution of statistical analyses per SAP in collaboration with programming and CRO partners to ensure timely delivery of results.
• Provides statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables to meet project milestones.
• Communicates project status regularly to management and escalates issues or risks in a timely manner to minimize delays.
• Provides statistical input and review for clinical study reports, regulatory documents, and publications to ensure accuracy and compliance.
• Performs quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
• Leads or supports regulatory interactions on statistical issues, providing applicable statistical strategies to address concerns.
• Delivers statistical presentations to internal and external stakeholders, or regulatory authorities as needed to facilitate understanding and decision-making.

To be successful in this role, the ideal candidate should possess:

• A Master's degree or PhD in Biostatistics, Statistics, or related quantitative field required.
• Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates.
• Proficiency in statistical programming in SAS, knowledge of R and other programming languages preferred.
• Solid knowledge of statistical methodologies and clinical trial designs.
• Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application.
• Experience with regulatory support and interaction.
• Experience providing statistical oversight of vendors and managing CRO collaborations.
• Proven ability to manage multiple studies and timelines concurrently.

The role of Senior Biostatistician plays a pivotal part in leading and overseeing statistical strategies to support the success of clinical trials. Reporting directly to the Head of Biostatistics, this position is responsible for planning, executing and interpreting statistical analyses across development programs.

• Serving as biostatistics lead for assigned studies and projects
• Leading or contributing to study design discussions, including protocol development, endpoint definition, and sample size estimation
• Authoring and reviewing Statistical Analysis Plans (SAPs), including mock tables, figures and listings (TFLs)
• Oversight and execution of statistical analyses per SAP in collaboration with programming and CRO partners
• Providing statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
• Regular communication of project status to management and escalation of issues or risks in a timely manner
• Providing statistical input and review for clinical study reports, regulatory documents, and publications
• Quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
• Leadership or support in regulatory interactions on statistical issues and provision of applicable statistical strategies to handle clinical and regulatory considerations
• Delivery of statistical presentations to internal and external stakeholders, or regulatory authorities as needed
• Contribution to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelines
• Familiarity with CDISC Standards, including SDTM, ADaM
• Maintenance of up-to-date knowledge with emerging statistical methodologies and evolving clinical trial practices

• A Master's degree or PhD in Biostatistics, Statistics or related quantitative field, required
• A minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates
• Proficiency in statistical programming in SAS. Knowledge of R and other programming languages preferred
• Thorough understanding of statistical methodologies and clinical trial designs
• Strong comprehension of CDISC standards (e.g., SDTM, ADaM) and their application
• Experience with regulatory support and interaction
• Experience providing statistical oversight of vendors and managing CRO collaborations
• Demonstrated ability to manage multiple studies and timelines concurrently
• Exceptional verbal and written communication skills, with ability to explain statistical concepts to non-statisticians
• Ability to work collaboratively within cross-functional teams and effectively convey one's perspective
• Demonstrated ability to communicate statistical concepts and results clearly and effectively
• Interest in and capacity to learn clinical drug development processes
• Able to work independently with minimal supervision

The Senior Biostatistician leads statistical strategies and deliverables in support of clinical trials under the guidance of Head of Biostatistics, ensuring high-quality timely deliverables that meet regulatory and scientific standards.

Key Responsibilities:

• Serves as biostatistics leader for assigned studies and projects, overseeing all aspects of data analysis and interpretation.
• Leads study design discussions, including protocol development, endpoint definition, and sample size estimation, to ensure effective and efficient trial execution.
• Authors and reviews Statistical Analysis Plans (SAPs), including mock tables, figures, and listings, to ensure accuracy and compliance with internal standards.
• Oversees execution of statistical analyses per SAP in collaboration with programming and CRO partners, ensuring seamless integration and delivery of results.
• Provides statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables to meet project timelines and budget.
• Communicates project status to management, escalates issues or risks in a timely manner, and provides regular updates on progress.
• Provides statistical input and review for clinical study reports, regulatory documents, and publications, ensuring high-quality and compliant outputs.
• Performs quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards, identifying areas for improvement and implementing corrective actions as needed.
• Leads regulatory interactions on statistical issues, providing applicable statistical strategies to handle clinical and regulatory considerations, and ensuring compliance with relevant regulations and guidelines.
• Delivers statistical presentations to internal and external stakeholders or regulatory authorities as needed, effectively communicating complex statistical concepts and findings.