We're seeking an Associate Director of Statistical Programming to lead statistical programming activities for clinical development programs and manage vendor oversight. This role will collaborate closely with Biostatisticians, data managers, and cross-functional teams, and will be an in-house expert in programming and data standards.
Key Responsibilities:
Lead and manage programming for clinical trials, ensuring quality and adherence to timelines.
Collaborate on programming strategies and support regulatory submissions.
Develop and maintain analysis datasets, tables, and figures following CDISC standards.
Provide technical guidance to cross functional teams and vendors.
Stay current with industry trends and introduce innovative solutions.
Requirements:
MS in Statistics, Computer Science, Life Sciences or related field with 8+ years of experience in statistical programming.
Expert in SAS programming and macro development.
Familiarity with ICH guidelines, CDISC standards, and regulatory requirements. Oncology experience preferred.
Extensive experience in early-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
Experience in NDA/BLA or other regulatory filings.
Strong communication, and organizational skills.
Working Place:
Boston, Massachusetts, United States
Numbers & Facts
Location
Boston, Massachusetts
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Skills
Analysis Skillsunmatched
Biologyunmatched
Biostatisticsunmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Trialunmatched
Clinical Trial Managementunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Cross-Functionalunmatched
Data Managementunmatched
Data Setsunmatched
Drug Developmentunmatched
ICH Regulationsunmatched
Industry/Trade Analysisunmatched
Maintain Complianceunmatched
Oncologyunmatched
Organizational Skillsunmatched
Project/Program Managementunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Statistical Analysis System (SAS)unmatched
Statistical Programming Languagesunmatched
Statisticsunmatched
Team Lead/Managerunmatched
Technical Leadershipunmatched
Vendor/Supplier Managementunmatched
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