118 Biostatistician jobs in India

• Designing study protocols, including defining endpoints, statistical analysis plans, and data collection methods.
• Performing sample size calculations and power analyses to ensure adequate study power.
• Developing and implementing statistical analysis plans (SAPs) for clinical trials and research studies.
• Analyzing complex datasets using statistical software (e.g., SAS, R, SPSS).
• Interpreting statistical results and preparing comprehensive reports for regulatory submissions and publications.
• Collaborating with investigators and research teams to ensure data quality and integrity.
• Contributing to the development of data management plans and case report forms (CRFs).
• Staying current with advancements in statistical methodologies and their application in biomedical research.
• Presenting findings to internal teams and external stakeholders.
• Ensuring compliance with Good Clinical Practice (GCP) and relevant regulatory guidelines.

AL Solutions are partnered with a mid-sized CRO who are searching for a freelance Biostatistician to work on an FSP basis and support their Oncology focused client.

This is a full time, fully remote contract that will run for 12 months with possibility of extension.

• Design statistical analysis plans (SAPs) for oncology clinical trials and observational studies.
• Perform statistical analyses using SAS, R, or other relevant tools.
• Support protocol development, sample size calculations, and randomization schemes.
• Analyze data from clinical trials, registries, and real-world datasets (e.g., Flatiron, CPRD, HES).
• Contribute to regulatory documents (e.g., CSR, ISS/ISE, CTD modules) and scientific publications.
• Provide statistical input during study design, interim analyses, and final reporting.
• Collaborate with medical writers, data managers, and clinical teams to ensure data integrity and consistency.
• Apply advanced methodologies such as survival analysis, Bayesian modeling, and indirect treatment comparisons (e.g., NMA, MAIC).

Title: Senior Biostatistician

Location: Remote/ Bangalore, India

Contract: 3 Months

Primary Purpose

Leads collaborations with clinical investigators to determine study design, contributes to protocol development, authors statistical analysis plans, performs statistical analysis, makes statistical inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. Manages statistical activities for a clinical study or platform of clinical studies.

Responsibilities

• May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies.
• Provides expert consultation to projects across the company on statistical methodology.
• Solves problems of complex statistical scope.
• Provides technical review of proposed statistical design for research studies across company.
• Serves as the lead Biostatistician on one or more study projects.
• Participates in statistical process development and improvement across company.
• May present at statistical conferences.
• Provides sound strategic, scientific and statistical input to support client’s research projects.
• Leads the project team’s development of study analysis plans and statistical programs to perform analyses and display study data.
• Keeps abreast with current statistical and medical literature to ensure that sound methodologies are adopted.
• Fosters innovation in Biostatistics that will continuously enhance current statistical knowledge and practices.
• Ensures the scientific integrity of the research project and the accuracy of the reported results.
• Performs sample size calculation and provides leadership in the statistical design of research projects.
• Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
• Develops study assignment allocation schemas along with appropriate documentation.
• Leads the development of the methods and results sections of clinical study reports and scientific publications.
• Represents EMMES on behalf of clients at regulatory meetings.
• Provides expertise in methodological advances both internally and externally to improve statistical methodologies.
• Participate in the development and updating of Standard Operating Procedures.

Qualifications

• MS in biostatistics, statistics, or PhD in biostatistics, statistics, epidemiology or related field
• At least 4 years of related experience with MS or 1 year of related experience with PhD is expected but not required.
• Experience with methodological statistical research, including publication and/or presentation of work in statistical methods development.
• Demonstrated proficiency with statistical methods and applications in clinical research.
• Strong programming skills in SAS and/or R.
• Expertise in state-of-the-art data manipulation and statistical methodology.
• Excellent communication, interpersonal and organization skills.
• Ability to manage multiple tasks.
• Ability to work independently, as well as in a team environment.
• Ability to effectively communicate complex statistical concepts, both written and oral

Experience

• 7+ Years

Education

• Master's degree in Statistics or equivalent

• Ph.D. in Statistics or equivalent & ≥ 4 years of industry related experience

Skills to have

• Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals

• Excellent verbal and written communications skills.

• Ability to be flexible and adapt quickly to the changing needs of the organization.

• Ability to organize multiple work assignments and establish priorities.

• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

Sr. PS Specifics

• Extensive knowledge of statistical / clinical trials methodology as it relates to clinical development

• Demonstrated data analysis planning, execution and delivery experience in multiple clinical development setting, e.g. different diseases, indications, development phase

• Past submission and regulatory interaction experience

The Biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS (Global Biometric Sciences) Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a GBDS Lead.

The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician III has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.

• Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate

• Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product

• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.

• Translates scientific questions into statistical terms and statistical concepts into layman terms

• Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information

• Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis

• Communicates effectively with clinical and regulatory partners and external opinion leaders

• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents

• Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted

• Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables

• Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information

• Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles

• Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.

• Drives alignment at study team level, and escalates lack of team alignment to the GBDS Lead for resolution

• Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions

• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.

• Keeps up to date with state-of-the art applied statistical methodology

• Understanding of CDISC standards and implementation guides

• Independently leads the development and execution of statistical aspects for multiple or complex studies

• Leads portions of filing activities (e.g., multiple protocols, single indications) including planning for and execution of integrated analyses.

• Defends protocols and SAPs at PRC reviews and provides independent reviews.

The Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client’s R&D sponsored clinical trials. Under the guidance of Head of Biostatistics, this role contributes to the planning, execution and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Essential Functions

• Serve as biostatistics leader for assigned studies and projects
• Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation
• Author and review Statistical Analysis Plans (SAPs), including mock tables, figures and listings (TFLs)
• Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners
• Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
• Regularly communicate project status to management and escalate issues or risks in a timely manner
• Provide statistical input and review for clinical study reports, regulatory documents, and publications
• Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
• Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
• Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed
• Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelines
• Good knowledge of CDISC Standards, including SDTM, ADaM
• Stay current with emerging statistical methodologies and evolving clinical trial practices
• Perform other duties/tasks as required or assigned

Minimum Education, Knowledge, Skills, and Abilities

• Master’s degree or PhD in Biostatistics, Statistics or related quantitative field, required
• 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 is 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 timeline concurrently
• Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians
• Ability to work as a team and have skills to convince your position within cross-functional teams
• Demonstrated ability to communicate statistical concepts and results clearly and effectively
• Interest in and ability to learn clinical drug development processes
• Able to work independently with minimum supervision

• Provide statistical expertise for the design of clinical trials, including sample size calculations, randomization schemes, and protocol development.
• Develop and execute statistical analysis plans (SAPs) for pre-clinical and clinical studies.
• Perform complex statistical analyses using SAS, R, or similar statistical software.
• Interpret statistical results and prepare integrated summaries of efficacy and safety for regulatory submissions (e.g., FDA, EMA).
• Collaborate with clinical development teams, data management, and other functions to ensure accurate data collection and analysis.
• Review and critique statistical methodologies used by external partners.
• Contribute to the development of statistical best practices and standard operating procedures.
• Mentor and guide junior biostatisticians within the team.
• Present statistical findings to internal teams, regulatory agencies, and at scientific conferences.
• Ensure compliance with all relevant regulatory guidelines and internal policies.