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Senior Manager, Statistical Programming (Remote)Penfield Search Partners • Fairfield, CT, US
Senior Manager, Statistical Programming (Remote)

Senior Manager, Statistical Programming (Remote)

Penfield Search Partners • Fairfield, CT, US
2 days ago
Job type
  • Full-time
  • Remote
  • Quick Apply
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.
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Senior Manager, Statistical Programming (Remote) • Fairfield, CT, US

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