Senior Manager, Statistical Programming
$146.6k - $184.6kPTC Therapeutics Inc
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
Vacancy posted a month ago
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