Associate Director, Statistical Programming

Job Description:ESSENTIAL FUNCTIONSLeads the statistical programming project team (including Clinical Research Organization (CRO) oversight as necessary) in support of clinical development programs in the assigned therapeutic areas.Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.Participates in study team meetings as a representative of the Biostatistics function. Communicates statistical issues and acts as a statistical/programming resource to the development teams.Participates in the assessment, selection and evaluation of CROsInteracts with CROs involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables; works with vendor staff to characterize and resolve issues related to data analysis.Creates/Reviews derived dataset specifications and the related analysis datasets.Develops SOPs and training guidelines related to statistical programming.May manage, coach and mentor direct reports.Performs other tasks and assignments as needed and specified by management.KNOWLEDGE/SKILLS/ABILITIES REQUIREDMaster’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 OR a 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 environmentDemonstrated 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 as related to drug development.Proficiency with Microsoft Office.Excellent verbal and written communication and skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Experience working directly with CROs.Experience supporting New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) submissions.0 - 10%$173,000 - $212,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.#LI-NM1

Created: 2025-12-04