Job Description

Friday, October 28, 2022 9:20 AM We’re hiring!   At Cognizant we have an ideal opportunity for you to be part of one of the largest companies in the digital sector worldwide. A Great Place To Work where we look for people who contribute new ideas, experiencing a dynamic and growing environment. At Cognizant we promote an inclusive culture, where we value different perspectives providing career growth and development opportunities. #WelcomeToCognizant! We have an exciting opportunity for an exceptional individual to work supporting one of our clients as a Team Lead - Biostatistics Your role  As a Biostatistician, you’ll work on a variety of projects, with responsibility for:  - Act as SME for team members in resolving any technical and operational issues - Development and/or review of Statistical Analysis Plan (SAP), including Table Shells and analysis datasets specifications - Understanding client’s requirement and providing all the required statistical inputs on study design, sample size, SAP, Mock Shells, Tables, Listings, Figures, CSR or any other statistical deliveries. - Provide statistical support for case report form design, database development, data validation plan and blinded data review as and when required. - Conduct literature searches to support statistical analysis. - With minimal or no oversight, perform statistical programming to generate tables, listings, figures, and statistical analysis for efficacy outputs. - Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health authorities. - Participate in client or regulatory audits. - Guide cross functional teams - Data management and medical writers for all trial related activities. - Plan and Manage timelines for assigned projects for self and team. Be responsible for day to day progress of work. - Responsible for performance management of team through goal setting and periodic reviews. - Provide input into the learning and career plans for team members - Ensure completeness of individual training records/ log and update their training plan as per role requirement/s - Mentor, Coach junior biostatisticians in statistical aspects of clinical trial. Contribute to and participate proactively in knowledge sharing sessions - Manage employee retention. - Contribute to Recruitment activities as required   What you need - A minimum of 5 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) - Good understanding of the Biostatistics domain and related processes - Independently interact with client and handle/address any queries from client - Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. - Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents (e.g. USFDA and EMEA) - Good knowledge of statistical programming languages (including SAS) and R will be added advantage - Adherence to SOPs and GPP - Ensure teams compliance to organizational policies and procedures - Quality and adherence to timelines. - Self-motivation and self-learning - Achievement orientation - Relationship building ability - Inclination towards being process driven     Why Cognizant?   Improve your career in one of the largest and fastest growing IT services providers worldwide Receive ongoing support and funding with training and development plans Have a highly competitive benefits and salary package Get the opportunity to work for leading global companies We are committed to respecting human rights and build a better future by helping your minds and the environment We invest in people and their wellbeing.  We create conditions for everyone to thrive. We do not discriminate based on race, religion, color, sex, age, disability, nationality, sexual orientation, gender identity or expression, or for any other reason covered.   At Cognizant we believe than our culture make us stronger!  Join us now! #BeCognizant #IntuitionEngineered