Sr. Manager / AD Statistical Programming

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At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.

Essential Functions:

We seek an exceptional full-time Senior Manager or Associate Director of Statistical Programming to join our Data Science Team. This position will lead or support project statistical programming activities; provide vendor oversights and programming supports to statisticians in production of summary tables, data listings, and graphs required for clinical trials, and CDISC datasets for regulatory submission. This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process. This position may provide statistical programming expertise on departmental and cross-functional process improvement initiatives. The position will report directly to the Director of Biostatistics.

Key Responsibilities:

  • Lead the Statistical Programming and in partnership with the Director of Biostatistics and other key stakeholders, help shape the overall Data Science Team strategy for the company as it pertains to systems infrastructure, standards and processes.
  • Serve as a Statistical Programming expert and be responsible for providing data functional input and oversight of clinical studies at the program level on multidisciplinary project teams
  • Serve as point-of-contact for projects’ entire statistical programming efforts, including but not limited to development and validation of technical programming specifications and programs, and generation of SDTM and ADaM datasets, as well as production of SAP specific tables, listings, and figures/graphs.
  • Oversee the generation of validated, reproducible, visualizations and analysis using open-source software packages or tools (e.g., R/R-Shiny, Spotfire) to replicate more formal (study-specific or integrated) analyses for the purpose of clinical trial planning and design, internal data review, go/no-go decision-making and external publications or data releases

Preferred Experience and Education:

  • Bachelor’s or Master’s degree in a data science field or relevant industry experiences.
  • Minimum 8+ years of biotechnology or pharmaceutical experience, with inflammatory disease experience preferred
  • Proficient in SAS and comfortable in R required
  • In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, etc.)
  • Solid understanding of industry standards such as CDISC, specifically SDTM and Controlled Terminology and/or ADaM
  • Represent Statistical Programming as study lead, focusing on data integrity, collaboration and on-time deliverables
  • Manage and provide oversight of contractors and CRO vendors
  • Interact with members of project teams, statistician and data management personnel to establish project timelines and perform planned and ad hoc statistical analyses
  • Provide support in production of summary tables, data listings, and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission
  • Provide programming support for development or verification of data and analysis
  • Provide guidance and QC/QA standards to ensure quality of deliverables

Salary Range for Sr. Manager: $165,000 – $175,000

Salary Range for AD: $185,000 – $195,000

The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.

DISCLAIMER

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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