We are looking for an Associate Lead Statistical Programmer in Global Development (GD) unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.
The position
As an Associate Lead Statistical Programmer you will be responsible for statistical programming and review of SAS programs in the designated clinical trial, prepare statistical programming specification and programming plan, set up meta data, create derived datasets, develop and review custom programs, use standards for analysis and reporting where applicable, check data before Database Lock (DBL) meeting, perform final run, freeze of data and create End-of-Text (EOT) material, lead pooling and reporting of data for integrated summaries, when relevant, participate in integration and reporting of Global Safety and DM data for Investigators Brochure, when relevant, communicate and collaborate with Contract Research Organisations (CRO) statistical programmers and off shoring partners, review CRF and TVP as required.
You provide resource estimates for programming needs to the Lead Programmer/International Lead Programmer on an ongoing basis and you are responsible for planning and coordination of programming tasks in clinical trials, including contribution to programming task prioritisation within the trial.
You assist less experienced statistical programmers in preparing statistical programming specification and programming plan, peer-review the programs written by less experienced statistical programmers for any assigned clinical trial, attend study group meetings with less experienced statistical programmers, as part of mentoring.
Contribute to the improvement of new and existing standards - take lead on global process improvement initiative(s), continuously improve programs and identify areas where output standards should be used, communicate trial specific programming improvements in the organisation - ensure communication to global Anchor group, give input to internal courses or seminars and train in programming best practise, assist in preparing training material for internal trainings, take a lead role in the exchange of knowledge and experiences within the team of statistical programmers
Qualifications
You need to have the below knowledge and skills.
BSc. or equivalent qualifications
At least 6-9 years of experience working as a statistical programmer within the pharmaceutical industry
Experience with the statistical software package SAS
Extensive experience with reporting clinical trials, including statistical data handling, analysis and reporting
Extensive experience with validation and documentation of programs
In-depth knowledge of drug development
Experience with clinical database technologies, data models and advanced programming
Experience with collaboration across professional and regional borders
Regular experience with communication and presentations
In-depth knowledge of computer systems and IT
Good knowledge of GxP and guidelines within drug development
About the department
The Global Development (GD) Global Business Service (GBS),Biostatistics and Programming department was established in August 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.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference.
Contact
Shiva K on SV*K@no********k.com
Deadline
25 December2020.
Keyskills: SAS Clinical Trials Adam Biostatistics senior programmer Statistical Programming Clinical Development sas programmer statistical programmer CRF lead programmer Statistical Analysis Senior statistical programmer
We are a leading global healthcare company, founded in 1923 and headquartered in Denmark.Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders.We do so by pioneering scientific breakthroughs, expandin...