Job Seekers, Please send resumes to resumes@hireitpeople.com
Key Responsibilities:
Include but are not limited to:
- Provide quality deliverables by following corporate and departmental policies, procedures and applicable standards.
- Perform data manipulation, analysis and reporting of clinical trial data.
- Create analysis files, tables, listings, and figures and validation of those files.
- Maintain project tracking and validation documentation.
- Work well in an environment where team members may be distributed across multiple locations.
- Review planning documents (Statistical Analysis Plan, dataset specifications, etc.) to ensure project objective alignment, clarity, accuracy, and completeness of programming requirements.
- Present statistical programming concepts to non - programming team members, as necessary.
- Collaborate effectively with cross-functional teams and interface with multiple stakeholders to manage timelines and priorities.
- Serve as back-up to Sr. Statistical Programmer II as needed.
Basic Qualifications:
- BA/BSc in Statistics, Mathematics, Computer Science, Life Sciences, or other related scientific subject with at least 7 years of relevant experience or masters degree and at least 5 years.
- Excellent analysis and reporting skills.
- Command of drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.
- Knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards.
- Ability to work effectively and successfully in a dispersed team environment with cross-cultural partners.
- Excellent oral and written English communication skills.
- Excellent time management skills, able to meet required timelines.
- Ability to provide quality output and deliverables, in adherence with timelines.
- Willingness and ability to learn and follow standard processes and procedures.
Preferred Qualifications:
- Familiarity with other programming languages (e.g. Java, R, or S-Plus).
- In depth knowledge of SAS Graph and Stat packages.
- Prior regulatory submission experience.
Experience required: 5-7 Years