- Manipulation of data to generate analysis datasets, including SDTM and ADaM datasets
- Production and review of Tables, Figures, and Listings (TFLs) as per the statistical analysis plan
- Creation and review of programming specifications and potential annotation of case report forms (CRFs) to CDISC standards
- Program of complex non-efficacy outputs/figures
- Development and debugging of complex macros
- Creation, Quality Check, and update of elaborate dataset specifications for single/multiple studies (including efficacy)
- Review of simple study design SAP autonomously
- Independent review of all shells with feedback provision
- Identifying data errors and liaising with client data management teams
- Assist internal management in evaluating resource requirements for project completion
- Adherence to industry (CDISC) and client standards
- Specializing in late-phase GI studies
- Bachelor's, Master's, or Ph.D. in Mathematics, Science, or IT-related field
- Over 6 years of experience in clinical trials, essential within a CRO, pharma, or academic environment
- Minimum of 5 years in SAS programming, essential
- 5+ years of CDISC (SDTM and ADaM) experience
- Knowledge of FDA CRT requirements included
- Team leadership experience preferred but not mandatory
- Excellent written and verbal communication abilities
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Senior Statistical Programmer I/II - Canada - PHASTAR
2 weeks ago
Description
Overview
COMPANY Phastar is a highly esteemed global biometric Contract Research Organization (CRO), recognized as an exceptional company to work for by Best Companies. Collaborating with pharmaceutical, biotechnology, and medical device firms, Phastar offers top-notch biostatistics, programming, data management, and data science services. Operating from multiple locations worldwide, Phastar stands out as the second-largest specialized biometrics provider globally and the largest in the UK, renowned for its unique data analysis approach, 'The Phastar Discipline', emphasizing exceptional quality. If you are passionate about quality and technical expertise, come join our team!
WHY PHASTAR Accredited for workplace excellence, Phastar values employee engagement, job satisfaction, and a healthy work-life balance. Offering flexible working arrangements, part-time options, involvement in company-wide initiatives, structured training programs, and a supportive, engaging, and cheerful work environment. Moreover, by joining Phastar, a tree will be planted in your honor as part of our Environmental, Social, and Governance (ESG) initiatives. Not only will you land your dream job, but you'll also contribute to saving the planet.
THE ROLE As the demand for our Functional Service Provision grows, we seek a skilled and ambitious Statistical Programmer to join our FSP team at the Senior I or Senior II level. This role involves supporting a prominent pharmaceutical client in the US remotely, focusing on late-phase GI studies. As an FSP Senior Statistical Programmer I/II, you'll play a pivotal role in technical programming, contributing significantly to the FSP team. This presents an excellent opportunity to work in a thriving CRO known for its emphasis on continuous learning and development, providing firsthand experience in a pharmaceutical setting.
Responsibilities
Qualifications
Important Notice to Employment Businesses/Agencies Phastar does not entertain referrals from employment businesses or agencies concerning the vacancies advertised on this site. Any such entities must first contact Phastar's Head of Talent Acquisition for explicit written authorization before proposing any candidates. The acquisition of written consent is a fundamental condition preceding any agreement between the employment business/agency and Phastar. Non-compliance with this policy may absolve Phastar of any liability for fees resulting from actions performed without consent or referrals made by employment entities regarding the posted vacancies.
