Principal Statistical Programmer

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

📋 Description

• Operate autonomously with concept-level guidance and minimal oversight.

• Monitor progress and deliver expert technical assistance to team members.

• Contribute to clinical development initiatives across various therapeutic fields.

• Help oversee CRO programmers to guarantee uniform, high-quality data summaries.

• Execute reporting and analytical tasks for Sponsor clinical trials.

• Produce SDTM and ADaM specifications, datasets, review guides, and Define.xml files for multiple studies.

• Create SAS programs that generate datasets, complex listings, tables, descriptive and inferential statistics, and intricate graphs.

• Develop, validate, and maintain SAS and/or R programs for clinical development projects.

• Supervise CRO statistical programming deliverables for several clinical studies.

• Assist in clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses.

• Adhere to FDA regulations, good clinical practices, and electronic submission guidelines.

• Establish, maintain, document, and validate standards for programming tools, outputs, and macros.

• Engage in the development of CRFs, edit check specifications, and data validation strategies.

• Review and/or draft data transfer specifications for external vendor data.

• Collaborate with CROs, software vendors, clinical development partners, and internal teams to achieve project deadlines and objectives.

• Review and/or author SOPs and work instructions pertaining to statistical programming practices.

⛳️ Requirements

• A minimum of a bachelor’s degree in computer science, data science, mathematics, or a statistics-related field is preferred.

• Over 7 years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or a comparable group.

• Experience in supporting drug development, medical device creation, or intervention studies.

• Exceptional SAS programming capabilities and proficiency in developing and executing statistical programming procedures and processes within a clinical development framework.

• Extensive practical experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations.

• Experience assisting with regulatory submissions and engaging with the FDA and/or global regulatory bodies.

• Ability to work independently is essential.

• Excellent written and verbal communication skills along with strong leadership abilities.

• Preferred: prior experience with pharmacokinetic data and in the neuroscience sector.

• Preferred: familiarity with tools other than SAS, such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git.

🏝️ Benefits

• Continuous training, development, and support.

• Significant opportunities for professional growth.