Sr Biostatistician

Emerald Clinical; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Emerald Clinical is seeking a Senior Biostatistician to lead global biostatistics activities, including design, analysis and reporting of medical research projects.

You will act as a biostatistical consultant across departments, stay current with statistical methodologies and regulatory requirements, and participate in regulatory meetings or DSMC activities as needed. The role requires strong experience in clinical trial statistics and collaboration across teams.

Qualifications

• M.Scs. or Ph.D. in Biostatistics, Maths or science related field.
• Minimum 7 years experience in Biostatistics or related work.
• Prior experience in the CRO environment is preferable.

Responsibilities

• Serve as a biostatistical consultant for other members of the department and staff from other departments within the company.
• Maintain knowledge of developments in biostatistics and trial methodology and regulatory requirements.
• Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a DSMC.
• Contribute as a biostatistician on projects including protocols, analysis plans, randomization plans, and reporting sections (ISSs, ISEs, and NDA sections).
• Coordinate and support internal and contracted staff in accordance with policies and regulations.
• Participate in project meetings and stay updated on project issues.
• Coordinate and participate in process improvements; oversee metrics; implement new guidelines and tools.
• Advise on resource allocation to achieve utilization and project realization targets.

Skills

SAS Programming

Microsoft Office

Education

M.Scs. or Ph.D. in Biostatistics, Maths or science related field

Job description

Job Summary

The Senior Biostatistician is responsible for global biostatistics activities. The Senior Biostatistician is responsible for the design, analysis and reporting of medical research projects conducted by Emerald Clinical.

Responsibilities

• Serve as a biostatistical consultant for other members of the department and staff members from other departments within the company;
• Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses.
• Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee;
• Participate as biostatistician on project(s) including but not limited to developing/reviewing protocols, preparing analysis plans, randomization plan, and writing sections of joint clinical/statistical reports, ISSs, ISEs and/or NDA sections, programming/ validation of TLFs and performing other relevant activities as required;
• Coordinate and support internal and contracted staff in accordance with organization s policies and applicable regulations.
• Participate in project meetings; keep up to date on project issues;
• Coordinate and participate in process improvements and interoffice/ interdepartmental task forces; oversee collection and reporting of Biostatistics metrics, implementation of revised work practices, new guidelines, and new software tools as they become available;
• Make recommendations about resource allocation for team members to achieve target utilization rates and project realization rates;

Training, Quality and Compliance

• Complete mandatory training for this role within specified timelines
• Attend mandatory training sessions required for this role
• Identify resources and training to support learning and development within this role Comply with all applicable regulations, guidelines, SOPs and project-specific requirements.
• Comply with all designated systems relevant to this role.
• Ensure own quality control of all relevant processes and activities performed
• Report and escalation identified risks and issues in areas of responsibility according to Emerald Clinical and/or project requirements

Customer Focus and Teamwork

• Attend and actively participate in Emerald Clinical meetings and other internal meetings and activities as required
• Provide input to systems, tools and processes to support continuous improvement Share knowledge with others, to facilitate learning and development across the organization

Work Health and Safety

• Comply with Work Health Safety (WHS) legislation and operate in accordance with established organisational WHS practice and procedures
• Promote and contribute to a safe, secure environment for staff and visitors

Qualifications

• M.Scs. or Ph.D. in Biostatistics, Maths or science related field
• Minimum 7 years experience in Biostatistics or related work Prior experience in the CRO environment is preferable

Competencies

• Experience in SAS Programming is an added advantage
• Technological proficiency including Microsoft Office packages
• Ability to see the big picture, yet still focus on detail and quality of work
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments

Locations: Bangalore, India

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.