Principal Statistical Programming Analyst

4 weeks ago

San Diego, California, United States Neurocrine Biosciences Full time
About the Role:


We are seeking a highly skilled Principal Statistical Programming Analyst to join our team at Neurocrine Biosciences. As a key member of our Biometrics department, you will play a lead role in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet project requirements.

Your Key Responsibilities:

  • Provide advanced technical expertise to the development of programming standards and procedures.
  • Participate in hiring, training, and oversight of statistical programmers to support the analysis and reporting of data from clinical and nonclinical studies.
  • Serve as the lead on projects and primary Statistical Programming point of contact on large, multidisciplinary projects company-wide.
  • Provide technical direction in the development and implementation of programming standards and conventions, building statistical programming infrastructure.
  • Contribute to the assessment of workload and projects to ensure appropriate programming resources are available to complete tasks in a timely manner.
  • Oversee and validate vendor programming activities such as CDISC implementation, analysis reporting, and programming conventions.
  • Support the creation and validation of e-submission requirements, including annotated CRF, datasets files, and define documents.
  • Serve as primary/lead programmer for agency reporting deliverables, such as DSUR/Annual Report and IB updates.
  • Perform the function of lead and/or quality control statistical programmer on projects as needed.

Requirements:

  • BS/BA degree in computer science, mathematics, statistics, or related discipline and 8+ years of experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph), CDISC data structures.
  • At least three years of experience serving in a supervisory or lead capacity.
  • Experience managing large projects and external vendors.
  • Advanced SAS programming skills and expertise in the development and implementation of statistical programming SOPs and processes in a clinical environment.
  • Experience working with early phase development studies preferred.
  • Knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems.
  • Experience in project management with minimum supervision.
  • Advanced understanding of relational databases and experience working with complex data systems.
  • Demonstrates expert knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Advanced programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar.
  • Advanced knowledge of SDTM domains, ADaM data sets, and files with proficiency in creating specification files for these domains.
  • Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines.
  • Works to improve tools and processes within functional area.
  • Developing reputation inside the company as it relates to area of expertise.
  • Ability to work as part of and lead multiple teams.
  • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
  • Excellent computer skills.
  • Excellent communications, problem-solving, analytical thinking skills.
  • Sees broader picture, impact on multiple departments/divisions.
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
  • Excellent project management skills.
  • Proficiency with Word, Excel, and PowerPoint is required as is the ability to communicate effectively both verbally and in writing.

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