ASSOCIATE DIRECTOR, STATISTICAL PROGRAMMING

PTC Therapeutics - Lakewood, CO

Full-time - Senior

Lakewood, CO

Chemical Manufacturing

About the position

The Associate Director, Statistical Programming at PTC Therapeutics is responsible for providing technical leadership and operational oversight for statistical programming activities that support multiple clinical development programs and regulatory submissions. This role involves guiding the development and review of statistical programming Standard Operating Procedures (SOPs) and processes, managing direct reports, and collaborating cross-functionally with internal departments and external resources. The incumbent ensures adherence to regulatory requirements and company SOPs while leading statistical programming project teams and communicating statistical issues effectively.

Responsibilities

• Lead the statistical programming project team in support of clinical development programs.
• Ensure timely statistical analyses of clinical data per protocols and Statistical Analysis Plans.
• Develop statistical programs and produce programmed outputs for integrated scientific reports.
• Participate in study team meetings as a representative of the Biostatistics function.
• Communicate statistical issues and act as a statistical/programming resource to development teams.
• Assess, select, and evaluate Clinical Research Organizations (CROs).
• Interact with CROs to ensure accurate and consistent statistical analyses and outputs.
• Create and review derived dataset specifications and related analysis datasets.
• Manage internal contractors and junior programmers, providing mentorship as needed.
• Develop SOPs and training guidelines related to statistical programming.
• Perform other tasks and assignments as specified by management.

Requirements

• Master's degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 7 years of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.
• Bachelor's degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 9 years of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.
• Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems.
• Working knowledge of R.
• Expertise in the implementation of Clinical Data Interchange Standards Consortium (CDISC) standards.
• Applied knowledge of clinical data analysis and reporting processes related to drug development.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
• Analytical thinker with excellent problem-solving skills and adaptability to changing priorities and deadlines.
• Excellent planning, organization, and time management skills.

Nice-to-haves

• Experience working directly with CROs.
• Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.