Job Description :
Purpose :
- Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures.
- Interpret analyses and write statistical sections of study reports.
- Provide training, guidance and mentorship to lower level and new staff.
- Desired Profile :
- Excellent written and oral communication skills including grammatical/technical writing skills
- Excellent attention and accuracy with details
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
- Strong individual initiative
- Strong organizing skills
- Strong working knowledge of SAS computing package
- Familiarity with other relevant statistical computing packages such as StatXact
- Strong commitment to quality
- Ability to effectively manage multiple tasks and projects
- Ability to provide and accept direction of lead team members
- Ability to solve moderately complex problems
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Working knowledge of relevant Data Standards (such as CDISC/ADaM)
Educational Qualification and Experience :
PhD in biostatistics or related field; Master's degree in biostatistics or related field and 5-7 years relevant experience in clinical domain only.
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