Senior Statistical Programmer / Statistical Programmer II

at  Parexel

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

SENIOR STATISTICAL PROGRAMMER KNOWLEDGE AND EXPERIENCE REQUIRED:

• Competent in written and oral English.
• Excellent communication skills.

EDUCATION:

• Educated to degree level in a relevant discipline and/or equivalent work experience.

STATISTICAL PROGRAMMER II JOB PROFILE SUMMARY:

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

SKILLS REQUIRED FOR SP II LEVEL:

Excellent analytical skills.
Proficiency in SAS with sound Statistical Programming experience within a related environment.
Knowledge and understanding of the programming and reporting process.
Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
Ability to learn new systems and function in an evolving technical environment.
Ability to manage competing priorities and flexibility to change.
Attention to detail.
Ability to successfully work as part of a global team.
Work effectively in a quality-focused environment.
Effective time management in order to meet daily metrics or team objectives.
Show commitment to and perform consistently high quality work.
Business/operational skills that include customer focus, commitment to quality management, and problem solving.

KNOWLEDGE AND EXPERIENCE:

Good clinical statistical programming skills and experience (2 years + experience).
Competent in written and oral English.
Good communication skills.

EDUCATION:

Educated to degree level in a relevant discipline and/or equivalent work experience.

ESSENTIAL SKILLS REQUIRED FOR THIS SENIOR STATISTICAL PROGRAMMER ROLE:

• Excellent analytical skills.
• Proficiency in: SAS, SDTM, CDISC, ADaM
• Extensive knowledge and understanding of the programming and reporting process with sound Statistical Programming (Clinical) experience within related industry (minimum 3.5+ years)
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Strong project management skills.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail.
• Ability to successfully lead a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Good business awareness/business development skills (including financial awareness).