Biotech/Pharmaceutical

Principal Statistical Programmer

Permanent

Penfield Search Partners

Contact: Linda Aronova –  laronova@penfieldsearch.com

Job Description: As Principal Statistical Programmer, you will lead programming support to oncology studies in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, validate and document SAS programs in accordance with company, industry, and regulatory requirements; you will play a key role in developing, implementing and evaluating statistical programming standards and processes; serve as expert on CDISC data standard; develops global macros to improve efficiency and capacity of statistical programming function. The position will provide you opportunity to demonstrate your project management and project leadership skills as well as opportunity for professional growth

Responsibilities:

  • Manage and lead all programming activities in multiple studies; lead the development of timelines and resource plan
  • Work with biometric team to develop submission strategy and lead programming team to create submission package
  • Create/review programming plan, specifications for datasets and TLFs. Expert level of understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models
  • Develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in compliance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures
  • Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions to identified issues; ensure datasets are in compliance with submission standards
  • Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements
  • Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
  • Familiar with ICH guidelines, advanced knowledge of submission requirements and standards, ensure that statistical programming deliverables are in compliance with regulatory requirements, industry and company standards
  • Having expert level of SAS programming expertise, develop global macro tools that can improve overall efficiency and capacity of programming function
  • Participate or lead the development, implementation and continuous improvement of programming process and standard
  • Effectively communicate in a project team environment, within department, among functional groups and external collaborators
  • Perform other programming duties as assigned

Qualifications:

  • Minimum of BS required in Statistics, Computer Science, Life Sciences or other related fields
  • BS with 8+ years or MS with 6+ years of SAS programming experience in drug development in CRO or pharma/biotech company; experience with R language is a plus
  • Good written and verbal communication skills
  • Oncology and submission experience preferred

Tagged as: Principal Statistical Programmer