Biostatistician 2

Job ID 288431BR

Position Title Biostatistician 2

40 + different analysis including clinical trials, scientific analysis, health authority responses, publication requests, patient access services, etc, are being worked upon at any point of time. The Biostatisticians work on real world data/ evidence or clinical trials on Gene therapy-based drug products or apply adaptive designs to find new biomarkers or automate devices for diagnosis.

From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams and publication teams, we analyze tons of data, deriving relevant insights that enable us to deliver innovative medicines to millions of patients worldwide.

Your responsibilities include, but are not limited to:

• Responsible for the statistical activities and support on statistical solutions for trials/publications and conferences. 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 in-to 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, and scientific analytical solutions.

• Ensure high quality for all assigned deliverables and processes and ensure audit-readiness.

• 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.

Minimum requirements

• MS/ MSc (in Statistics or equivalent) with 2+ years relevant work experience or PhD (in Statistics or equivalent). Fluent English (oral and written)

• Working knowledge of/experience with SAS/ R or any other business or research analytic software with an expertise in at least one type of software.

• Statistical and computational knowledge and expertise in analytic aspects.

• Excellent interpersonal and communication skills. Good understanding of global clinical trial practices, procedures, methodologies.

• Good understanding of regulatory requirements for design, analysis and reporting of clinical trials.

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Division NBS

Business Unit PLS NBS

Site Hyderabad, AP

We use science-based innovation to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to provide a shareholder return that rewards those who invest their money, time and ideas in our company.