Senior Manager, Statistical Programming

PTC Therapeutics seeks a Senior Manager of Statistical Programming to lead programming activities for clinical development studies, oversee CRO partnerships, and ensure timely statistical analyses and regulatory compliance. The role involves cross-functional collaboration and may include SOP development for biostatistics processes.

Responsibilities

• Lead statistical programming activities for assigned clinical development studies and programs
• Ensure timely statistical analyses per protocols and Statistical Analysis Plans, directly or through CRO oversight
• Participate in study team meetings as Biostatistics representative and communicate statistical issues
• Assess, select, and evaluate CROs; interact with vendors to ensure accurate analyses and resolve data-related issues
• Review Case Report Forms, Statistical Action Plans, and derived dataset specifications

Requirements

• Master's degree in quantitative discipline (Statistics, Mathematics, Computer Science)
• Minimum 5 years pharmaceutical, biotechnology, CRO, or related statistical programming experience
• Demonstrated SAS programming expertise (Base SAS, SAS/Stat, SAS/Graph, macros, ODS)
• Working knowledge of R and CDISC standards
• Knowledge of clinical data analysis and reporting in drug development
• Excellent verbal and written communication skills
• Strong problem-solving and analytical skills with ability to manage multiple priorities

Compensation: $146,600 - $184,600 base salary