Job title: Clinical Statistical Programmer
Company: Katalyst Healthcares & Life Sciences
Job description: Responsibilities:
- provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.
- Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders.
- Accountability for 5+ concurrent studies.
- Represent the Statistics function in study team meetings.
Requirements:
- Masters or PhD in Statistics is required.
- 5 years recent/related statistical experience within a pharmaceutical and/or medical device company, or similar organization is required.
- Ability to manager 5+ studies at a time is required.
- Experience with different clinical phases.
- Knowledge of clinical trial methodology and study design.
- Study-level statistical expertise.
- Proficiency in SAS and knowledge of CDISC standard.
- Strong working knowledge of statistical data analysis and data management principle.
- Actual med device experience.
- Ability to be proactive.
Expected salary:
Location: South Plainfield, NJ
Job date: Sun, 08 Sep 2024 06:12:23 GMT
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