Statistical Programmer-II (FSP)

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.

Job Qualifications

• Deliver best value and high quality service.

• Check own work in an ongoing way to ensure first-time quality.

• Use efficient programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.

• Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.

• Maintain and expand local and international regulatory knowledge within the clinical industry.

• Develop knowledge of SAS and processes/procedures within other Parexel functional areas.

• Provide relevant training and mentorship to staff and project teams as appropriate.

• Excellent analytical skills.

• Proficiency in SAS.

• 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.

• Competent in written and oral English.

Experience:

• Candidates must have minimum of 3+ years of statistical programming in clinical/pharma domain 

• Strong programming and analytical skills using SAS software

• Good knowledge and understanding of CDISC SDTM, ADaM and Define.xml standards & TLF’s

• Proven knowledge of regulatory guidance documents

• Proven understanding of clinical trials, fundamentals of clinical research, GCP

• Strong communication (verbal and written) & interpersonal skills

• Good team player, self-disciplined & self-motivated with ability to learn faster 

Education:

• A Masters in statistics, mathematics, or another relevant discipline. Or B.Sc., Life Science Graduates/ Statistics Graduate/ SAS certified preferable.