Senior Statistical Programmer (UK, FSP)

Parexel International Corporation

Sheffield, England, United Kingdom

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act 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 Primary Statistical Programmer role on projects, and liaise with sponsors, Biostatistics Leads, and other functional areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

• Ability to fill Primary Statistical Programmer role on projects (Input into and negotiate statistical programming timelines, Ensure that timelines are adhered to, Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget, Monitor project resourcing, project budgets, and identify changes in scope).

• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

• Review statistical analysis plans and mock-shells.

• Review database set-up specifications and third-party vendor data transfer specifications.

• Interact with sponsors with regard to statistical programming issues.

• 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/QC SDTM datasets, ADaM datasets, tables, figures, and data listings.

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

• Produce/QC SDTM dataset specifications, ADaM dataset specifications, and other process supporting documents including submission documentation.

• Interact with sponsors with regard to statistical programming issues.

• 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.

• Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas.

• Maintain all supporting documentation for studies in accordance with SOP's/Guidelines to ensure traceability and regulatory compliance.

• Ensure compliance with SOP's/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.

• Proactively participate in process/quality improvement initiatives.

• Provide consultancy to internal and external sponsors with regard to statistical programming tasks.

• Represent Parexel at sponsor marketing and technical meetings.

• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).QualificationsSkills / Experience

Sound Lead Statistical programming experience within related industry is essential (min 6 years).

Proficiency in SAS Knowledge of the programming and reporting process.

Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement.

Demonstrate ability to learn new systems and function in an evolving technical environment.

Strong leadership ability.

Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently. Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.

Attention to detail.

Excellent analytical skills.

Good presentation skills.

Tenacity to work in an innovative environment.

Ability to negotiate and influence in order to achieve results.

Business/Operational skills that include customer focus, commitment to quality management and problem solving.

Good business awareness/business development skills (including financial awareness).

Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.

Work effectively in a quality-focused environment.

Demonstrate commitment to refine quality processes.

Effective time management in order to meet daily metrics or team objectives.

Show commitment to and perform consistently high quality work.


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

Language Skills

Competent in written and oral English. Excellent communication skills.

2020-07-09 01:00:45

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