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Manager/Sr. Manager, Statistical Programmer

Cambridge, MA

Posted: 02/08/2021 Employment Type: Direct Hire Job Category: Clinical: Biometrics Job Number: 2698

Job Description

The Manager/Sr. Manager Statistical Programmer will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for manuscripts and presentations.

This is an onsite position and reports to Director, Statistical Programming, working closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs.

  • Function as lead programmer to produce and/or validate tables, listings, figures and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
  • Develop/review TFL shells and SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
  • Works closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
  • Partner with or oversee CROs or Programming vendors to perform the tasks described above.
  • Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
  • Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
  • Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
  • Performs tasks with minimal instruction from supervisor.

  • A Master’ s Degree in statistics, mathematics, computer science, or related scientific/medical field is a must.
  • 8+ years of (SAS) statistical programming experience in a clinical trial setting (industry/CRO).
  • Advanced SAS programming skills – procedures and options commonly used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures desirable.
  • Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards.
  • Ability to effectively manage multiple tasks and projects.
  • Strong interpersonal communication skills and passion for excellence.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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