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Job Description Contact: Lauren Scutero - lscutero@penfieldsearch.com No 3rd party candidates The Senior Manager of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks. This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data

Additionally, this position will play an important role in establishing SOPs and programming standards, and modernizing statistical reporting with open-source tools. Essential Duties and Responsibilities Key Project Responsibilities: Provide programming leadership and oversee study to compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams. Serve as the lead programmer to review the SAP, Data Presentation Plan, and Table Shells to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.

Lead programming team to produce and/or validate SDTM, ADaM, and TLF for CSR and regulatory requests, publication needs, and ad-hoc analyses. Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence. Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.

Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team. Develop robust programs to create define.xml

Lead the NDA eSubmission package preparation. Initiative Responsibilities: Under the guidance of the Head of Statistical Programming and Compound Lead, implement innovative strategies and technologies to enhance programming processes. Working with the manager, establish Statistical Programming standards and deploy programming strategies, specifications, and programmed analyses.

Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability. Qualifications and Preferred Skills Education: Master's degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field. Experience and Skill Set: Minimum of 6 years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment.

Advanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming. Python programming experience is desirable.

Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements. Good knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology. Broad expertise in statistical programming and in developing computing strategies.

In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials. Knowledge of data validation, define.xml generation using Pinnacle 21. Results-oriented, with proven problem-solving skills and a strong interest in continued learning

Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams. Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors. Adaptable and able to thrive in a fast-paced, startup environment while managing multiple priorities effectively.

Experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.