Job Description

40+ analysis including trials, analysis, health authority responses, publication requests, access services, etc, are being worked upon at any point of time. The Statistical Programming team is a function where we are empowered to experiment, explore and progress beyond the boundaries of outstanding Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.

Job Purpose

The Biostatistician 2 will be responsible for delivering statistical analytic solutions for Medical Affairs studies (MA), Non-Interventional studies (NIS), Scientific Analytics studies and multiple Phase I-IV clinical trials at a trial level by executing statistical analyses plans, ensuring high quality and timely production of statistical reporting deliverables (analysis datasets, tables, listings and graphs). Supervise CROs as required and ensure timely deliverables.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Responsible for the statistical activities and support on statistical solutions for trials/publications and conferences including assigned RWE studies. Activities include providing input on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses.
• Support trial statistician in transcribing statistical analysis plans of clinical studies into computational solutions for the statistical programmer to implement. Transcriptions include specifications of derived variables, specification and development of statistical computing solutions for inferential statistical analyses, tables and listings templates, and modern statistical graphics for key reporting documents like the clinical study report.
• Ensure that documents, specifications, programs/macros are consistent and comply with Clinical Science Unit (CSU)/project/company standards/processes. Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, scientific analytical solutions, RWE studies and analysis as needed.
• Ensure high quality for all assigned deliverables and processes and ensure audit-readiness. Competency with SAS / R programming and comfortable working on the SAS server, GPS, LSH, DaVinci platform, EVICO and other tools. Support Trial Programmer with SAS codes for efficacy analyses and/or debug SAS codes related to statistical methods.
• Responsible for ensuring statistical deliverables are provided to agreed timelines. Maintain and build effective relationships with internal and external customers, utilizing support of management as needed. Collaborate with other line functions. Explain statistical concepts in a manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
• Participate in non-clinical project activities as needed. Take on role of mentor and provide support for Biostatistician 1.