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

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