Senior Manager, Statistical Programming (Remote)

Contact: Lauren Scutero -
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.

• 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 . Lead the NDA eSubmission package preparation.

• 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.

• Masters degree in Statistics/Biostatistics Mathematics Computer Science or a related field.

• 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 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.