Senior Biostatistical Programmer
6 days ago
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:
- Manage assigned programming CROs providing oversight and appropriate QC for programming deliverables.
- Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
- 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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India K3-Innovations, Inc. Full timeJob OverviewThe Statistical Programmer at K3-Innovations, Inc. will provide support for statistical programming activities across various clinical trials and regulatory submissions. The ideal candidate will have a strong background in statistics and biostatistics, as well as experience working with pharmaceutical companies.
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