Senior Statistical Programmer

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

📋 Description

• Conducting data manipulation, analysis, and reporting of clinical trial data related to 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.

• Developing complex ad-hoc reports utilizing raw data.

• Demonstrating a strong understanding and experience in efficacy analysis.

• Drafting and reviewing submission documents and electronic Case Report Templates (eCRTs).

• Liaising with internal cross-functional teams and clients regarding project specifications, statuses, issues, or inquiries.

• Taking on lead responsibilities when necessary.

• Collaborating as a team player, willing to go the extra mile to achieve results and meet deadlines.

• Exhibiting adaptability and flexibility as priorities shift.

⛳️ Requirements

• A bachelor’s degree in fields such as Statistics, Computer Science, Mathematics, etc.

• A minimum of 8 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry with 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 simultaneously.

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

• Solid experience with the latest CDISC SDTM / ADaM standards.

• Strong quality control/validation skills.

• Good ad-hoc reporting capabilities.

• Proficiency in efficacy analysis.

• Familiarity with the drug development life cycle and experience in manipulating, analyzing, and reporting clinical trial data.

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

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

• Excellent analytical and troubleshooting skills.

• Ability to deliver quality outputs and meet challenging timelines.

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

🏝️ Benefits

• Our dedication to developing our staff is only matched by our commitment to enhancing treatment options available to patients.

• Cytel is a workplace where talent, experience, and integrity unite to elevate the field of clinical development.