Senior Statistical Programmer

2 weeks ago

bangalore, India Novo Nordisk AS Full time

Department- Biostatistics

Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? If so, there is a job opportunity waiting for you as our new Senior Statistician . At NovoNordisk, we will challenge you to do the best work of your life. Apply Now.

About the Department :

Biostatistics department was established in October 2010. The team has a good blend of experience and fresh perspective and comprises experienced statisticians and programmers, who form the core of the team. The main purpose & objective is to ensure high quality in preparing and conducting statistical analysis in accordance with the project milestones and provide statistical support and expertise to all clinical development activities within Novo Nordisk.

The Position:

The Senior Statistical Programmer will be responsible for statistical programming and reviewing SAS/R programs in the designated clinical trial. Will also be responsible for sharing best practices and adhering to project and other programming standards, as well as guiding and mentoring less experienced statistical programmers.

Additionally, the Senior Statistical Programmer is accountable for:

Provide programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan. Responsible for creating and gathering input to the Specification ADRG for the clinical trial, and ensuring it is aligned with Project ADRG. Ensure that mock TFLs are created and reviewed by stakeholders. Programming/ review of ADaM, Safety and Efficacy TFLs according to specifications for Clinical Study Report, ISS/ISE etc. Ensure Trial execution and coordination within the trial statistics team. Responsible for the programming input to Risk Management Plan, Investigator's Brochure, DSUR /PSUR and regulatory submission documents To work closely with trial squad, take initiative, and help with methodological or technically challenging tasks where innovation is essential. Serve as point of contact for programmers from the functional suppliers regarding the programming need.

Qualifications

Bachelors or Masters in life sciences or natural sciences or Engineering or equivalent qualifications. 5 -8 Years of experience in working as a statistical programmer within the pharmaceutical industry. Experience with SAS programming, ADAM, CDISC (Clinical Data Interchange Standards Consortium), TLF (Technical loss factor), R Programming; expertise of reporting clinical trials, including handling, analysing, and reporting statistical data. Thorough experience of programme validation and documentation. Working Knowledge of advanced programming, data models, and clinical database technologies. Solid understanding of drug development. Excellent written and spoken English. Analytical and result oriented. Good team player with communication and stakeholder management skills.

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