PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: PK Analyst
Job Description:
The PK Analyst is responsible for the programming and validation of derived PK and PD datasets, tables, listings, figures, and statistical appendices. The PK Analyst is also responsible for performing non-compartmental analysis. The PK Analyst works in collaboration with other PK Analysts and PK Scientists in order to produce outputs and results of high quality, within the given timelines
Relationships
Reports To Worldwide (WW) Head of Clinical PK/PD and Pharmacometrics
Directly Supervises Not Applicable
Provides Work Direction to None
Works Closely with All functional groups, especially more senior PK Analysts, PK Scientists, Biostatisticians, Biostatistical Programmers, Data Managers, Project Managers, Project Leads and Medical Writers.
External Relationships Sponsors
Key Accountabilities
• Supports programming activities on a study-specific basis and 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).
• Performs derivation of PK/PD parameters using WinNonlin
• Creates/Review NONMEM datasets
• Programs and validates PK/PD derived datasets, listings, tables, figures and statistical appendices.
• Ensures that the deliveries match the agreed specifications. Supports quality control and quality audits of deliverables.
• Working according to International Conference on Harmonization Good Clinical Practice standards.
• Maintain a positive, results orientated work environment, building partnerships.
• Review/Contributes to scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans (including table/listing shells), ADaM specifications and Clinical Study Reports
• To attend Sponsor meetings and provide PK/PD input as needed
• Other duties as assigned.
Skills
• Good programming skills (main focus on SAS programming).
• Windows applications; Word (including adapting and writing macros); E-mail; Excel; Internet; Powerpoint.
• Professional attitude; Self-motivated; Logical thinking; Attention to detail; Client liaison; Able to work independently; First time quality; Communication of programming issues to non-technical staff.
• Excellent inter-personal, verbal and written communication skills.
• Client and quality focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Ability to work well under pressure and to keep scheduled timelines.
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Candidate Profile
Minimum Work Experience
• Two to five years of hands on programming experience in SAS®, preferably in the pharmaceutical industry.
• Knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH)
• Advantageous Experience
• Experience in other software such as –R, S-PLUS
• Knowledge of drug pharmacokinetics
• Basic Pharmacokinetics: Calculations and analyses
• Knowledge of PKS® (Pharsight)
• Knowledge of CDISC SDTM and ADaM datasets and standards
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).
Additional Information:
Location: Andhra Pradesh - Hyderabad
Functional Area: Pharmacokinetics
Requisition: pare-00022868
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 30th October, 2014
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