Senior Statistical Programmer, FSP

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Conducting data manipulation, analysis, and reporting of clinical trial data, focusing on both safety and efficacy through SAS programming.

• Creating and validating SDTM and ADaM datasets/analysis files, as well as tables, listings, and figures (TLFs).

• Engaging in production and quality control/validation programming.

• Producing complex ad-hoc reports using raw data.

• Demonstrating a strong understanding and experience in efficacy analysis.

• Developing and reviewing submission documents and electronic Case Report Forms (eCRTs).

• Interacting with and/or addressing inquiries from internal cross-functional teams and clients regarding project specifications, status, issues, or inquiries.

• Functioning as a collaborative team member, with a commitment to going above and beyond to achieve results and meet deadlines.

• Exhibiting adaptability and flexibility when priorities shift.

⛳️ Requirements

• Bachelor's degree in fields such as Statistics, Computer Science, Mathematics, or related disciplines.

• Minimum of 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry, holding a bachelor's degree or equivalent; at least 6 years of relevant experience with a master's degree or higher.

• Experience as a study lead, preferably managing multiple projects concurrently.

• Proficient in SAS data manipulation, analysis, and reporting techniques.

• Extensive experience in implementing the latest CDISC SDTM/ADaM standards.

• Strong quality control/validation capabilities.

• Effective ad-hoc reporting skills.

• Expertise in efficacy analysis.

• Understanding of the drug development life cycle and experience in the manipulation, analysis, and reporting of clinical trial data.

• Experience with submissions utilizing define.xml and other relevant submission documents.

• Background in supporting oncology or immunology studies is a plus.

• Excellent analytical and troubleshooting abilities.

• Capability to produce high-quality outputs and deliverables while adhering to demanding timelines.

• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

🏝️ Benefits

• Ongoing training, development, and support.