Lead Statistical Programmer

Location

Bangalore | India

Job description

Job description

Job Title: Lead Statistical Programmer

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 Lead 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 Lead 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 Lead 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.
• 7 + 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.

Working at Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

Apply before 15th March ,2024.

Working at Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

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