Senior Biostatistical Programmer

6 days ago


India K3-Innovations, Inc. Full time
Job Description

We are seeking a highly skilled Senior Biostatistical Programmer to join our team at K3-Innovations, Inc. in the development of clinical trials.

Job Summary:

  • Provide statistical programming support for the biostatistics and data management functions for all clinical trials and regulatory submissions.
  • Work closely with biostatisticians and data managers to support creating SAS programs for independently validating tables, listings, and figures produced by programming vendors.

Key Responsibilities:

  1. Manage assigned programming CROs providing oversight and appropriate QC for programming deliverables.
  2. Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
  3. Perform statistical analysis and simulations using SAS to support clinical trial design and data interpretation.

Requirements:

  • Bachelor's Degree or Master's degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 5-8 years of relevant experience in the pharmaceutical/biotechnology industry.
  • Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development.

Skills and Qualifications:

  • Knowledge of pharmaceutical and regulatory requirements, procedures, and policies.
  • Experience with BLA or NDA/sNDA submissions is a plus.
  • In-depth knowledge of CDISC and ADaM data set structures and requirements.
  • Proficiency with SAS programming skills, including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL).
  • Excellent computer skills; strong verbal and written communication skills.

Estimated Salary: $120,000 - $180,000 per year, depending on experience and qualifications.



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