Manager, Statistical Programming

$126,000 - $150,549/Yr

PTC Therapeutics - Remote, OR

Full-time - Manager

Remote, OR

Chemical Manufacturing

About the position

The Manager, Statistical Programming is responsible for overseeing programming activities related to clinical development programs and studies, either directly or through the management of Contract Research Organizations (CROs). This role involves developing and reviewing statistical programming standards, ensuring compliance with regulatory requirements, and collaborating with various internal and external stakeholders to address statistical programming issues.

Responsibilities

• Contributes to the statistical programming activities for assigned clinical development studies and programs.
• Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; develops statistical programs and produces outputs for clinical trial reports.
• Participates in study team meetings as a representative of the Biostatistics function.
• Identifies statistical issues and collaborates with the programming team to find solutions.
• Acts as a statistical/programming resource to development teams.
• Assesses, selects, and evaluates CROs for statistical programming tasks.
• Reviews Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs, and TLG shells.
• Interacts with CROs to ensure accurate and consistent statistical analyses and outputs.
• Creates and reviews derived dataset specifications and related analysis datasets.
• Develops SOPs and training guidelines related to statistical programming.
• Performs other tasks and assignments as specified by management.

Requirements

• Bachelor's degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science).
• Minimum of 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO, or related environment.
• Demonstrated SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS).
• Good understanding of database systems and working knowledge of R.
• Experience with Clinical Data Interchange Standards Consortium (CDISC).
• Knowledge of clinical data analysis and reporting processes related to drug development.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Strong analytical thinking and problem-solving skills.
• Excellent planning, organization, and time management skills.

Nice-to-haves

• Master's degree in a quantitative discipline (e.g., Statistics, Mathematics, Computer Science).
• Experience working with CROs.
• Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.

Benefits

• Short- and long-term incentives.
• Medical, dental, and vision insurance.
• Retirement savings plans.