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Job Details

Principal Statistical Programmer (Bloemfontein, South Africa)

Company: PAREXEL
Location: Bloemfontein, Orange Free State,South Africa
Reference: 49136BR
Closing Date: 18 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

• Leads programming activities within the assigned clinical trial 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 (SOP's).• Programs and documents derived datasets, listings, tables, figures and statistical appendices for mainly safety, pharmacokinetics and pharmcodynamics.• Performs pharmacokinetic and pharmacodynamic modeling using WinNonlin. ...

Requirements:

• Leads programming activities within the assigned clinical trial 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 (SOP's).
• Programs and documents derived datasets, listings, tables, figures and statistical appendices for mainly safety, pharmacokinetics and pharmcodynamics.
• Performs pharmacokinetic and pharmacodynamic modeling using WinNonlin.
• Ensures that the deliveries match the agreed specifications. Supports quality control and quality audits of deliverables.
• Providing technical advice and support to Biostatistical Programmers and Associate Biostatistical Programmers within the company.
• If needed, prepares datasets for electronic submission to regulatory authorities in line with applicable policies and SOP's.
• Working according to International Conference on Harmonization Good Clinical Practice standards.
• Maintain a positive, results orientated work environment, building partnerships and co-coordinating teamwork, communicating to the team in an open, balanced, and objective manner.
• If needed, liaise with clients (via Project Managers if applicable) in sorting out any statistical or data issues and in delivering the required outputs.
• Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
• Other duties as assigned.Qualifications• Excellent SAS® programming skills (SAS/BASE, SAS/STAT and SAS/GRAPH).
• Windows applications; Word (including adapting and writing macros); Email; Excel – basic; Internet; PowerPoint; Statistical Methodology and procedures – basic; Statistical issues in clinical trials – basic; Role of clinical research organization (CRO) in clinical trials.
• Professional attitude; Self-motivated; Logical thinking; Attention to detail; Client liaison; Able to work independently; First time quality control; Communication of programming issues to non-technical staff; Good mentoring/leadership skills.
• Excellent interpersonal, 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.
• Ability to work well under pressure and to keep scheduled timelines.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• A 3 year degree or equivalent, in a programming discipline is preferable; Post graduate qualification is advantageous.
• Fluent in English (speak, read, write).
• At least 6 years of hands on programming experience in SAS®, preferably in the pharmaceutical industry.
• Basic to advanced pharmacokinetic knowledge regarding applicable variables, calculation methods, and statistical analyses/programming of these variables.
• Working knowledge of Clinical Data Interchange Standards Consortium (CDISC).
• Experienced in reporting databases and ADaM datasets.• Excellent SAS® programming skills (SAS/BASE, SAS/STAT and SAS/GRAPH).
• Windows applications; Word (including adapting and writing macros); Email; Excel – basic; Internet; PowerPoint; Statistical Methodology and procedures – basic; Statistical issues in clinical trials – basic; Role of clinical research organization (CRO) in clinical trials.
• Professional attitude; Self-motivated; Logical thinking; Attention to detail; Client liaison; Able to work independently; First time quality control; Communication of programming issues to non-technical staff; Good mentoring/leadership skills.
• Excellent interpersonal, 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.
• Ability to work well under pressure and to keep scheduled timelines.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• A 3 year degree or equivalent, in a programming discipline is preferable; Post graduate qualification is advantageous.
• Fluent in English (speak, read, write).
• At least 6 years of hands on programming experience in SAS®, preferably in the pharmaceutical industry.
• Basic to advanced pharmacokinetic knowledge regarding applicable variables, calculation methods, and statistical analyses/programming of these variables.
• Working knowledge of Clinical Data Interchange Standards Consortium (CDISC).
• Experienced in reporting databases and ADaM datasets.

Apply for this job: Principal Statistical Programmer (Bloemfontein, South Africa)

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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