Senior Statistical Programmer

Position Details

  • Job Title: Senior Statistical Programmer
  • Location: New York, NY (or East Coast Remote)
  • Job Category: Clinical

JOB SUMMARY

We are seeking a highly creative and self-motivated Senior Statistical Programmer with significant experience in drug development to work as a member of an integrated team translating Kallyope’s cutting-edge biology on the gut and gut-brain axis to transformational therapeutics.  The successful applicant will report to the Head of Biometrics and ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Kallyope regulatory, scientific and business objectives. Kallyope is based in New York City, but the right person for this role can be located anywhere on the East Coast.

KEY RESPONSIBILITIES

  • Work collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting
  • Generate or oversee the production of programming deliverables (e.g., tables, listings, figures) for study reports and integrated summaries
  • Delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations
  • Statistical programming deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs, and response to regulatory questions.
  • Anticipate resource needs and works with management to ensure adequate long-term resource allocation within a project
  • Manage outsourced vendor programmer teams
  • Design and/or code analysis files
  • Ensure programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
  • Support development operations functions by provide programmed outputs of end point data for centralized data review, ad hoc analysis, metrics reports
  • Provide review and input on relevant sections of clinical trial specifications (end point providers) are accurate and correct
  • Serve as a key resource on technical initiatives and may represent the Company on contracts

QUALIFICATIONS AND EDUCATION REQUIREMENTS

You must have:

  • BS degree in Biostatistics/Computer Science or equivalent and at least 8 years of experience or MS degree and at least 6 years of experience within the pharmaceutical and/or biotech industry
  • Experience in CDISC, ADaM, SDTM deliverables for regulatory submissions (e.g., NDA MAA) within the biotech industry
  • Excellent verbal and written communication skills and interpersonal skills
  • Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions
  • Ability to interact with others to define and produce user-defined statistical reports (e.g., ad hoc requests)
  • Ability to resolve study related issues and conflicts within a therapeutic project
  • Can create buy-in and support and has the ability to negotiate timelines
  • Ability to directly supervise personnel

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