Lead Statistical Programmer

at  Orion Corporation

Orion’s Research and Development Organisation is looking for a talented professional to join us in the dynamic fields of Clinical Operations and Data Science.

DESCRIPTION OF POSITION

The Lead Statistical Programmer is a contributor with knowledge of statistical programming, data standards and data structures. As the Lead Statistical Programmer, you will leverage your programming skills to support clinical trials, with a focus on the Oncology and Pain indication areas.

Main responsibilities

• Coordinate and participate in the development and validation of high-quality standardized datasets based on the CDISC guidelines, utilizing mainly SAS programming
• Act as the CDISC subject matter expert and ensure compliance of CDISC SDTM and ADaM datasets
• Lead building of submission-ready datasets and documentation
• Designs and develops statistical programs to support of clinical research analysis and reporting activities (like tables, listings, and figures)
• Coordinate resource allocation on designated studies and projects (both inhouse and insourced resources)
• Lead development of the programming activities, implement advanced AI driven technologies in the clinical data process
• Provide mentorship and training to peers and more junior programmers in areas of expertise

DESCRIPTION OF UNIT

Clinical Operations and Data Science is the competence and resource center for clinical studies in Orion R&D. Key responsibilities of the center include medical writing, study management, data management, programming, data engineering and biostatistics. The organization provides operational clinical services for the Oncology and Pain Therapy Areas.

REQUIREMENTS

To be the successful Lead Statistical Programmer you should have the following educational and professional work experiences:

• BSc/ MSc degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics. Experience with the curation, analysis and reporting of research data
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) compliance, Study Data Tabulation Model (SDTM) and the Analysis Data Models (ADaM) for regulatory submissions is desirable
• Advanced programming skills (e.g. SAS, R, Python), analysis and reporting skills
• Experience in developing and implementing statistical programming strategies
• Capable of providing quality control review for programming
• Clinical trials knowledge, including knowledge of applicable clinical research regulatory requirements

We are seeking an individual with strong leadership and management skills, capable of effectively guiding and inspiring teams to achieve their goals. The ideal candidate will also demonstrate the ability to work successfully in a globally dispersed team environment, collaborating seamlessly with cross-cultural partners to drive innovation and excellence in Clinical Operations and Data Science.

#LI-ORION

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.
Orion Corporation operates in more than 30 countries, where we Orionees, 3600 in total, work in all kinds of positions. Among us there are Research Scientists, Laboratory Technicians, Engineers and IT Specialists as well as people working in Production, just to mention some examples. We offer diverse and responsible jobs to our personnel in a truly multi-disciplinary work environment. We encourage people to develop their competences and offer opportunities to affect the job description and creating their own career path at Orion. We are searching for top talents who are ready to share our passion for the work that we do

• Coordinate and participate in the development and validation of high-quality standardized datasets based on the CDISC guidelines, utilizing mainly SAS programming
• Act as the CDISC subject matter expert and ensure compliance of CDISC SDTM and ADaM datasets
• Lead building of submission-ready datasets and documentation
• Designs and develops statistical programs to support of clinical research analysis and reporting activities (like tables, listings, and figures)
• Coordinate resource allocation on designated studies and projects (both inhouse and insourced resources)
• Lead development of the programming activities, implement advanced AI driven technologies in the clinical data process
• Provide mentorship and training to peers and more junior programmers in areas of expertis