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.
