Associate Director/Director of Statistical Programming

📋 Description

• Lead statistical programming initiatives across clinical programs, ensuring the creation and quality oversight of tables, listings, figures, and analysis datasets. Perform exploratory statistical analyses to facilitate key decision-making.

• Supervise external functional service providers to guarantee timely and high-quality programming outputs.

• Create and uphold standards, guidance, applications, and processes for Statistical Programming operations in compliance with ICH and regulatory standards.

• Promote the use of innovative programming technologies and workflows to improve the efficiency of clinical data review, cleaning, reconciliation, and integration. Additionally, design analytical tools that support effective data monitoring and knowledge discovery within clinical data.

⛳️ Requirements

• BS/MS degree in life sciences, computer science, statistics, mathematics, or a related relevant field.

• Over 8 years of experience in statistics and programming with extensive expertise in the pharmaceutical and biotechnology sectors, including more than 5 years serving as a Lead Statistical Programmer across various therapeutic areas.

• Proven expertise in SAS, R, and R-Shiny, alongside mastery of complex graphing techniques for deriving analysis datasets, producing tables, figures, and listings, and conducting exploratory analyses.

• Proficient in developing open-source R packages and visual analytics for exploratory and interactive data analysis, visualization, and insight generation.

• In-depth knowledge of data standards including CDISC, SDTM, and ADaM, along with pertinent regulatory guidelines.

• Experience with regulatory submissions in the US, Europe, and other regions.

• Exceptional interpersonal and communication skills, including the ability to manage and resolve conflicts.

🏝️ Benefits

• Comprehensive benefits package

• Bonuses

• Equity compensation