Senior Statistical Programmer
Posted 22 days ago
You'll complete your application on Innovaderm Research Inc.'s career site.
About the Role
As a specialized contract research organization focused on dermatology, this organization manages clinical trials ranging from Phase I through Phase IV, with operations spanning North America and Europe. They provide a full range of expertise, including regulatory advice, project management, data management, and study design to achieve superior research results, building upon a foundation of quality and client satisfaction established in 2000. As a Senior Statistical Programmer, you will act as a primary lead on one or more clinical studies. You will work alongside biostatisticians and cross-functional teams to provide high-quality deliverables that adhere to strict budget and scheduling requirements. Furthermore, you will contribute to internal projects and help shape programming benchmarks, all while ensuring full adherence to pharmaceutical industry standards and regulatory expectations.
Requirements
- You must possess a Bachelor's degree in Computing Sciences, Statistics, or a related discipline; a Master’s degree is preferred.
- You require a minimum of five years working in clinical research within a biotech, pharmaceutical, or CRO setting.
- You must have at least four years of experience in statistical programming, with one year specifically in a lead role.
- You must demonstrate proficiency in SAS, with preference given to those experienced in XML programming.
- You need comprehensive expertise in CDISC standards, ICH guidelines, drug development cycles, and regulatory requirements from the FDA or Health Canada.
- You must be highly organized, possess strong communication abilities, and excel in dynamic work settings.
- You must hold legal authorization to work in the Philippines.
Responsibilities
- You will create, support, and verify ADaM and SDTM datasets, along with generating statistical listings, figures, and tables.
- You will produce annotated Case Report Forms and compile submission documentation for clinical study reports and interim analyses.
- You will offer feedback on shell documents, statistical analysis plans, and edit checks while assisting with the cleaning of data.
- You will utilize Pinnacle 21 to generate and test define.XML and PDF documents.
- You will improve operational efficiency through the use of global SAS macros.
- You will function as the primary unblinded or QC programmer for IDMC tasks and randomization schemes.
- You will help improve departmental programming workflows and provide guidance to less experienced staff members.
Benefits & Perks
- This is a permanent, full-time position that allows you to work from home.
- You will benefit from a flexible work schedule.
- You will have access to professional development and continuous learning opportunities.
- You will enjoy significant prospects for career advancement.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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