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Insmed

Develops therapies for rare diseases

Associate Director - Programming

Quantitative Biology & BiostatisticsUpdated on Nov 13
Full-timeRemote in USA

About the Job

Requirements

  • A master's degree in Biostatistics, Statistics, Computer Science, Data Science, or a related field, and 6 years of experience in statistical programming and analytics within pharmaceutical or biotechnology clinical development; alternatively, a bachelor's degree in those fields or a related field, and 10 years of such experience.
  • Proficiency in R and familiarity with the pharmaverse and tidyverse ecosystems for clinical data analysis and reporting.
  • Significant knowledge of the drug development process, clinical trial methodology, and regulatory requirements for drug approval.
  • Experience in global regulatory submissions.
  • Extensive knowledge of CDISC standards, including SDTM and ADaM dataset specifications and define.xml.
  • Ability to manage multiple studies within a program in a fast-paced environment, with experience in project management.
  • Experience with SAS.

Responsibilities

  • Serve as Program Lead Programmer for an assigned compound, leading programming activities and oversight to ensure quality and timeliness.
  • Act as Study Lead Programmer for one or more studies within the assigned compound.
  • Set programming strategy, tasks, priorities, and resources for the assigned compound.
  • Provide program-level programming leadership and support to clinical development teams.
  • Provide hands-on programming support for assigned studies and exploratory analyses, including responses to ad hoc requests from regulatory agencies.
  • Ensure deliverable quality by applying analysis and reporting standards and driving compliance with regulatory requirements, corporate and departmental SOPs, and Work Instructions.
  • Lead process improvement initiatives.
  • Provide technical guidance to programmers, contractors, and vendors on programming conventions, standards, practices, and specifications to ensure integrated computing solutions.
  • Review and/or author SOPs and Work Instructions related to statistical programming practices.
  • Contribute to creating, maintaining, and validating internal standards for programming tools, outputs, and macros.

Desired Qualifications

  • Experience with Python.
  • Experience developing R packages.

About the Company

Insmed

Develops therapies for rare diseases

Insmed focuses on developing and delivering therapies for serious and rare diseases. Its products come from a pipeline of clinical trials and approved treatments, sold to patients in global markets with offices in Bridgewater, NJ, Europe, and Japan. The company’s work combines research and development, regulatory approvals, and commercialization to bring therapies from discovery to patients. Insmed differentiates itself by addressing unmet medical needs in rare diseases and maintaining a global infrastructure that supports development, approval, and patient access. The goal is to improve patient outcomes by providing effective treatments for conditions with limited existing options.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
1988

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