Chief Statistical Programmer

4 days ago

Hyderabad, Telangana, India beBeeStatistical Full time US$ 2,00,000 - US$ 2,50,000

Seeking a seasoned professional to lead Statistical Programming initiatives. The successful candidate will oversee comprehensive programming solutions for clinical project teams and vendors, ensuring compliance with regulatory requirements and standards.

Key Responsibilities:

  • Develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
  • Lead electronic submission preparation and review
  • Communicate proactively and effectively around issues and risks and contribute to its remediation.
  • Identify, lead, and support opportunities to enhance processes and technology.
  • Effectively recruit, manage, develop, evaluate, reward, motivate, and retain up to 5 direct reports.

Minimum Qualifications:

  • Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required
  • At least 9+ years programming experience in industry including support of significant regulatory filings
  • Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
  • Broad expertise in statistical programming and in developing computing strategies.
  • In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML).
  • Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components).
  • Experience working in Therapeutic areas like Oncology, Immunology, Hematology and Medical Affairs.

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