Senior Statistician I | 6 to 9 yrs | Hyderabad , Bengaluru, Mumbai, Pune, Noida & Gandhinagar
Capgemini
5 - 10 years
Hyderabad
Posted: 11/08/2025
Job Description
Job Description
:We are seeking an experienced and collaborative Senior Statistician to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory compliance of statistical deliverables. The Senior Statistician will also oversee quality control processes and contribute to the development of statistical analysis plans and datasets.Key Responsibilities:Provide statistical leadership and support for clinical trials, ensuring high-quality deliverables.Participate in cross-functional study-related activities and team meetings.Perform sample size calculations and author or review statistical analysis plans (SAPs).Coordinate with Biostatisticians, Statistical Programmers, and Data Managers to prepare, conduct, and review statistical analyses.Ensure the accuracy and integrity of final statistical outputs and deliverables.Guide and supervise programmers in developing analysis dataset specifications and programming/validation of tables, listings, and figures (TLFs).Validate analysis variables and statistical outputs for consistency and compliance.Conduct quality control (QC) of data displays and analysis datasets prepared by others.Maintain project administration files including protocols, annotated CRFs, SAPs, annotated shells, programming/QC rules, tracking logs, and communications.Participate in internal meetings and contribute to Biostatistics and Development Team initiatives.
Primary Skill
s:Statistical Methodology: Advanced statistical techniques, sample size estimation, inferential statisticsProgramming: Proficiency in SAS and clinical data analysis toolsDocumentation: SAPs, annotated shells, QC logs, and regulatory documentationCollaboration: Cross-functional teamwork with clinical, data, and sponsor teamsLeadership: Project management and mentoring of junior team membersSecondary Skills:Regulatory Knowledge:Understanding of drug development and submission processesQuality Assurance:QC of datasets and statistical outputsCommunication:Clear and effective communication with technical and non-technical stakeholdersProject Organization:File management, version control, and audit readinessSoftware Proficiency:MS Word, Excel, PowerPoint, and project management toolsPreferred
Qualifications
:Master’s degree in Statistics or related field with 6+ years of industry experiencePhD in Biostatistics or related field with 3+ years of postgraduate experienceProven ability to lead projects and manage cross-functional teamsStrong foundation in statistical methodologies and SAS programmingExperience with clinical trial data analysis and regulatory submissionsWorks in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.
About Company
Capgemini is a global leader in consulting, technology services, and digital transformation. Headquartered in Paris, France, Capgemini provides a wide range of services, including IT consulting, managed services, business process outsourcing, and digital transformation solutions. With over 360,000 employees across more than 50 countries, the company focuses on helping organizations innovate and transform their businesses to remain competitive in a rapidly changing digital landscape. Capgemini is known for its expertise in cloud computing, AI, cybersecurity, and other emerging technologies, working closely with clients to develop sustainable and cutting-edge solutions.
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