PAREXEL - Biostatistical Programmer III

Essential Function:

- The Biostatistical Programmer III is responsible for the programming and quality control of derived datasets, tables, listings, figures, and statistical appendices of complex clinical trial projects, often with major regulatory impact. The Biostatistical Programmer III works in close collaboration with Senior Biostatistical programmers, Biostatisticians and Consistency Reviewers in order to produce outputs and results of high quality. The responsibilities will also include producing and coordinating the production of analysis datasets and addressing clients' specifications (mapping). The Biostatistical Programmer III is responsible for driving timelines within the programming team and report all delays and possible issues to the Manager.

Relationships:

Reports To- Manager Biostatistics (Local)

Directly Supervises- None

Provides Work Direction to - Biostatistical Programmers Level I and Level II

Works Closely with- All functional groups, especially programming team, Biostatisticians, Consistency Reviewers, PK Scientists and Analysts, Clinical Data Managers, Clinical Data Programmers, Project Managers and Medical Writers

External Relationships- Clients

Key Accountabilities:

- Programming activities within assigned clinical trial(s), ensures that all programming activities are executed in a timely manner and to the required high statistical and reporting standards as specified in Standard Operating Procedures (SOPs).

- Taking responsibility of driving timelines and liaise with programming team assigned to a specific project.

- Taking the lead in complex studies.

- Programs and documents derived datasets, listings, tables, figures and statistical appendices for mainly safety, pharmacokinetics and pharmacodynamics of complex study designs.

- Ensures that the deliveries match agreed specifications.

- Develop and present on-the-job training material to Level I and Level II programmers.

- Provide programming details to be included in Statistical Analysis Plans.

- If required, prepares datasets for electronic submission to regulatory authorities in line with applicable guidelines and requirements.

- Working according to International Conference on Harmonization Good Clinical Practice standards.

- Maintain a positive, results orientated work environment, communicating to the team in an open and positive manner.

- Mentoring Level I and Level II programmers.

- Other duties as assigned.

Skills

- Good SAS® programming skills (SAS/BASE, SAS/STAT, and SAS/GRAPH).

- Windows applications; Word (including adapting and writing macros); Email; Excel – basic; Internet; Powerpoint.

- Working knowledge of Clinical Data Interchange Standards Consortium (CDISC), ADaM datasets and define.xml.

- Professional attitude; Self-motivated; Logical thinking; Attention to detail; Able to work independently; First time quality.

- Excellent interpersonal, verbal, and written communication skills.

- Client and quality focused approach to work.

- A flexible attitude with respect to work assignments and new developments.

- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload.

- Value the importance of teamwork.

- Ability to work well under pressure and to keep scheduled timelines.

Education

- A 3 year degree or equivalent, in a programming discipline is preferable; Post graduate qualification is advantageous.

Language Skills

- Fluent in English (speak, read, write).

Minimum Work Experience

- At least 3 years of hands on programming experience in SAS®, preferably in the pharmaceutical industry.

- Knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH).

- Basic pharmacokinetics: Calculations and analyses.

- Basic Statistics.

Advantageous Experience

- Knowledge regarding creation and validation of SAS macros

- Knowledge regarding validation of software

Subramanyam Katperi
Talent Acquisition Team
PAREXEL INTERNATIONAL
11th Floor, Bldg No.20, Sundew Properties SEZ Pvt Ltd Mindspace,
Madhapur, Hyderabad, Andhra Pradesh, INDIA–500 081.
Office: +91-040-44379464,Mobile:+91-9000090203
Web: www.parexel.com
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