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Director, Statistical Programming

Posted 2024-11-12

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💎 Seniority level: Director, minimum of 15 years of relevant experience

📍 Location: United States

💸 Salary: 210000 - 230000 USD per year

🔍 Industry: Biopharmaceutical

🏢 Company: Praxis Precision Medicines, Inc.

🗣️ Languages: English

⏳ Experience: Minimum of 15 years of relevant experience

🪄 Skills: GCPAnalytical SkillsCollaboration

Requirements:
  • MS in Biostatistics, Statistics, Mathematics, Computer Sciences, Life Sciences, or equivalent.
  • Minimum of 15 years of relevant experience in statistical programming.
  • Excellent SAS programming and analytical skills, including SAS/BASE, SAS/STAT, and SAS/GRAPH.
  • Ability to perform simulations in programming languages, and proficiency in R and/or Python is a plus.
  • Extensive experience with IND/NDA activities and regulatory interactions.
  • Thorough knowledge of CDISC guidelines, particularly SDTM and ADaM, and fluency in Pinnacle 21 Enterprise Version.
Responsibilities:
  • Develop and maintain CDISC-compliant and submission-ready programs, including SDTM and ADaM.
  • Ensure accurate and statistically valid deliverables in protocols, statistical analysis plans, and regulatory submission documents.
  • Collaborate with clinical development, data management, and biostatistics teams for timely deliverables.
  • Monitor project progress and allocate resources effectively for successful outcomes.
  • Provide input for marketing application preparations to regulatory agencies.
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