Principal Statistical Programmer

1 month ago

bangalore, India Excelya Full time

Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya's vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.

To learn more about us, visit www.excelya.com.

The role:
Exceya is looking to collaborate with a full-time Principal Statistical Programmer based in India. Excellent knowledge of English and local language are required for this role.

Responsibilities:
To be the reference point in India, to be able to recruit, train and organize the team.
Responsible for providing SAS programming support in terms of SDTM and ADaM datasets and tables and listings (TFLS).
Support the creation or validation of SDTM, ADaM Specification and annotated CRF based on CDISC standards.
Skilful in SAS programming for Data Manipulation and Statistical Analysis
Adequate knowledge about other programming languages (e.g., R, Python) is a added advantage.
Ensuring compliance with regulatory requirement and company’s Standard Operational Procedures.
Prepare, maintain documentation of statistical programs and processes.
Work together with cross-functional teams to understand project requirements and proactively inform project lead/ manager about study related issues and delivery related issues.
Actively participate in training programs to enhance both technical and functional skills.
Stay informed about industry trends, programming techniques and regulations.

Qualifications:
Bachelor’s or master’s degree in Statistics, Biostatistics, Data Science, or an equivalent degree in Computer science or live science.

Experience:
Minimum 10-15 years of experience in statistical programming with proficiency in SAS programming and good understanding of SDTM and adequate knowledge about ADaM, Tables and Listings. At least 2-3 years of experience as manager or team leader.

Skills and abilities:
Skills in the use of word processing, spreadsheet, and presentation software.
Good analytical and problem-solving skills.
Effective communication skills and ability to work collaboratively with different stakeholders involved in study.
Deep Knowledge of programming logic and code.
Organized, independent, and accurate way of working and ability to maintain clear documentation.
Knowledge of clinical trial process and regulatory requirements is valuable.
Detail-oriented with a commitment to deliver high quality work.

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