Senior and Principal Statistical Programmer

2 weeks ago

delhi, India Akkodis Full time
About Akkodis
Akkodis is a global digital engineering company and Smart Industry leader. We enable clients to advance in their digital transformation with Talent, Academy, Consulting, and Solutions services. Our 50,000 experts combine best-in-class technologies, R&D, and deep sector know-how for purposeful innovation. We are passionate about Engineering a Smarter Future Together.
With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Job Location: Bangalore
JOB DESCRIPTION :
1 Brief description of the job
As a Clinical Statistical Programmer, you provide statistical programming expertise to deliver high
quality programs and outputs for analysis of clinical data. It is your responsibility to provide high
quality analysis results on time to support efficient decision making.
2 Description of tasks and responsibilities in each field
• Develop Analysis Data Model (ADaM) datasets
• Develop Tables, Figures and Listings / Output and Programming Specification (TFL/OPS) from the Statistical Analysis Plan (SAP) o r a related document
• Develop Define.xml and Analysis Data Reviewer’s Guide (ADRG) for data submission
• Program and validate standard ADaM and utility Statistical Analysis Software (SAS) macros or R function/package following good programming practices
• Act as a statistical programming representative within cross functional study teams and project sub teams and provide statistical support and solutions
• Provide input to internal process improvements and/or new statistical programming capabilities
• Maintain current scientific and regulatory knowledge
• Bsc. in Statistics, Mathematics, Informatics or equivalent
• At least 8 years of experience as a statistical programmer in the pharmaceutical industry
• Proficient in English (oral and written)
• Excellent programming skills in SAS (Macro, SQL) and R (function, package)
• Able to develop, validate and maintain programs
• Excellent understanding of the standardization and automatization processes
• Excellent knowledge of statistical concepts and statistics applied to non clinical, pre clinical and clinical data
• Excellent knowledge of GCP and ICH guidelines
• Excellent communication skills, able to build good relationships with internal and external stakeholders
• Team player, able to work in a multidisciplinary team
• Able to manage, drive and meet delivery timelines
• Excellent knowledge of CDISC standards (ADaM , SDTM)

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