Role & 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 organizations 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,



current 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;

Preferred candidate profile

- 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

Role: Other, Industry Type: Clinical Research / Contract Research, Department: Other, Employment Type: Full Time, Permanent Role Category: Other Education UG: Any Graduate Key Skills Skills highlighted with ‘‘ are preferred keyskills Biostatistics Clinical ResearchstatisticianSDTMAdam

📌 Senior Biostatistician / Biostatistician II (Bengaluru)
🏢 Emerald Clinical
📍 Bengaluru