Senior Statistical Programmer – FSP

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

📋 Description

• Conducting data manipulation, analysis, and reporting of clinical trial data, focusing on both safety and efficacy (ISS/ISE), using SAS programming.

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

• Engaging in production and quality control/validation programming.

• Generating sophisticated ad-hoc reports using raw data.

• Leveraging a robust understanding and experience in efficacy analysis.

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

• Communicating with and responding to internal cross-functional teams and clients regarding project specifications, status updates, issues, or inquiries.

• Taking on lead responsibilities when necessary.

• Demonstrating a team-oriented attitude, with a commitment to going above and beyond to achieve results and meet deadlines.

• Maintaining adaptability and flexibility as priorities evolve.

⛳️ Requirements

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

• A minimum of 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry, or equivalent experience with at least 6 years if holding a master’s degree or higher.

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

• Strong skills in SAS data manipulation, analysis, and reporting.

• Significant experience implementing the latest CDISC SDTM / ADaM standards.

• Proficient in quality control and validation processes.

• Competent in ad-hoc reporting.

• Proficient in efficacy analysis.

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

• Experience with submissions using define.xml and other submission documents.

• Experience supporting studies in immunology, respiratory, or oncology is advantageous.

• Exceptional analytical and troubleshooting abilities.

• Capable of delivering quality output and deliverables while adhering to tight timelines.

• Ability to work effectively and successfully within a globally distributed team environment, collaborating with cross-cultural partners.

🏝️ Benefits

• We are committed to applying scientific rigor to unlock the full potential inherent in data.

• We foster intellectual curiosity and encourage everyone to tackle new challenges with enthusiasm and a desire for discovery.

• We value collaboration and welcome diverse perspectives, leveraging a variety of talents to create a wealth of possibilities.

• We prioritize innovation and seek intelligent solutions through the use of advanced technology.