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Associate Director, Biostatistical Programming

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MEI Pharma, Inc.

2021-12-04 00:00:05

Job location San Diego, California, United States

Job type: fulltime

Job industry: Healthcare & Medical

Job description

Job Summary:

The Biostatistical Programming Associate Director at MEI Pharma will lead programming-related activities on multiple concurrent projects and oversee development of clinical study related deliverables and timelines for programming activities. The successful candidate will report to the Head of Biostatistical Programming at MEI.

Role and Responsibilities (Include but not limited to):

  • Lead study statistical programming, set and monitor programming related timeline
  • Oversee CRO activities, review CRO deliverables, and provide programming guidance for CRO
  • Monitor, analyze and report clinical trials data and generate outputs (Tables, Figures and Listings) according to study SAPs or ad-hoc request specifications in support of annual safety reports, study CSRs, regulatory submissions, business development activities and clinical publications
  • Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders
  • Perform quality control checks/validation of SAS programs and/or output produced by CROs for SDTM datasets, ADaM datasets, TFLs
  • Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness
  • Assist in the validation of derived datasets, programming specifications and tables, listings and graphs
  • Create and maintain documentation for analysis dataset specifications and validation
  • Review and make recommendations for process development and improvement
  • Provide technical leadership and guidance for programming team
  • Collaborate with cross-functional teams including Data Management, Clinical Operations, and Medical Monitoring at MEI and CROs to review eCRF design and specifications, edit checks, data validation specifications, perform document user acceptance testing (UAT) on databases, and conduct clinical data quality reviews by providing SAS checks to verify integrity and consistency for completeness, accuracy, and suitability

Qualifications:

  • Proven ability to manage CRO relationships and oversees programmed deliverables
  • Advanced skills in SAS programming and statistical reporting
  • In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements
  • Advanced knowledge with FDA and ICH regulations and guidelines, medical terminology and clinical trial methodologies
  • Good communication skills

Job Requirements and Education:

  • Master's degree in statistics, computer science or a related field with at least 10 years (or Bachelor degree in statistics, computer science or a related field with at least 12 years) of SAS programming experience in the pharmaceutical or biotech industry
  • 2 years + oncology experience preferred

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