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Senior Manager, Statistical Programming

Cambridge, MA

Posted: 10/10/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2461

Job Description


Reporting to an Associate Director of Statistical Programming, the successful candidate should be exceptionally experienced in directing and coordinating the activities of Statistical Programming staff assigned to projects. The Senior Manager works independently with only concept level instruction and very little supervision, delegates tasks appropriately, tracks progress, and provides expert technical support to team members. In addition, the Senior Manager fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer for large number of studies, including entire development programs.

Responsibilities:
  • Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
  • Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
  • Provides leadership to ensure compliance with company SOPs and FDA/ICH/GCP regulations
  • Participates in the development of overall objectives and influences long-term goals of the organizations
  • Regularly works with advanced features of SAS including interfacing ability with other software applications and operating system tools
  • Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with more significant consequences and impact
  • Applies in-depth knowledge and experience of software validation and system development life cycle to daily tasks
  • Applies experience to anticipate and proactively resolve project specific issues before they become problems
  • Participates on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, and acquisition, customization, and integration of new tools and technologies
  • May supervise other Statistical Programming staff
  • Performs other duties as assigned

Requirements / Qualifications:
  • MS in biostatistics or a related field, with 7 years of experience in pharmaceutical industry, or BS in statistics or related field, and 9 years of experience in pharmaceutical industry.
  • Experience with BLAs, MAAs and other regulatory submissions is a plus
  • Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Excellent and transparent communication skills and ability to influence across multiple functions.
  • Positive, outgoing and collaborative attitude

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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