Associate Director, Statistical Programming

PTC Therapeutics - Warren, NJ

Full-time - Mid Level

Warren, NJ

Chemical Manufacturing

About the position

The Associate Director, Statistical Programming provides technical leadership and operational oversight for statistical programming activities supporting clinical development programs and regulatory submissions. This role involves guiding the development of Standard Operating Procedures (SOPs) and participating in biostatistics computing systems implementations. The incumbent collaborates cross-functionally and may manage direct reports, ensuring adherence to regulatory requirements and company SOPs.

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 relevant experience, or a Bachelor's degree with a minimum of 9 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, or CRO environment.
• Demonstrated SAS programming skills (Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and 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 environment.
• Analytical thinker with excellent problem-solving skills.
• 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.