Dear Allstat,
Senior Statistical Programmer is urgently needed:
For responsible programming aspects (analysis datasets, pooled datasets,
listings and tables) of individual Phase I-IV clinical trials and project
level activities for small drug project/indications.
1. Lead the programming activities for a trial, early phase project,
indication, or publication activities; lead a complex/large project
under supervision of a Program Statistician / Group Head.
2. Maintain efficient interfaces with internal and external
customers with support of Statistical Reporting (SR)
management and the Program Statistician.
3. Develop resource plans as required with support of the Group
Head.
4. Develop and comply with project / study standards and
specifications following internal guidelines.
5. Make certain that documents and specifications are consistent and
comply with company standards by providing input into study
protocol, CRF and data structures tables, listings and figures for
phase I-IV clinical trials and submission activities.
6. Program, according to specifications, analysis datasets, pooled
datasets, listings, tables, and figures for phase I-IV clinical
trials and for SCS and SCE with high quality and within milestones.
7. In consultation with the statistician, develop specifications for
analysis datasets, pooled datasets, and listings.
8. Support quality control and quality audit of deliverables.
9. Maintain records for all assigned projects and archiving of trial
/ project analysis and associated documentation.
10. Participate in the selection of CROs and supervise the SR trial
activities of the CROs.
11. Provide input on process improvement initiatives and participate
in non- clinical project activities.
1. Adequate representation of SR in the Clinical Trial Team and
Biostatistics (B) &SR project team.
2. Effectiveness of communication and team behaviors as assessed by
the other members of the Clinical Trial Team and B&SR project
team.
3. Quality and timeliness of SR contributions as assessed by the
Clinical Trial Team, Program Statistician and Group Head.
Education
BA/BS or equivalent experience in mathematics,
(minimum/desirable): statistics, computer science or life sciences or
related field.
Languages: Fluent English (oral and written).
Experience/Professional
1. Intermediate knowledge of / experience with SAS
2. Working knowledge of database design/structures.
3. Good understanding of global clinical trial practices,
procedures,methodologies.
4. Good understanding of regulatory requirements relevant to SR (e.g.
GCP, ICH).
5. Intermediate knowledge of office tools.
6. At least 4 years experience in a programming role preferably
supporting clinical trials/ or in the pharmaceutical industry (2
years for Ms Statistics / Computer Science graduates).
I also have a variety of other Biometric specific vacancies available in the
UK and throughout Europe.
Inclusive of SAS programming, Statistical, Data Management functions, please
call me for further details....
If you would like to discuss this role in greater detail or your application
/ suitability to this or further roles, please call me or email me in
confidence. If you are not available or suited to this position, please feel
free to pass my details on.
For a confidential consultation call Mathew Hogan on 0044 (0) 207 255 6665
or email your CV to [log in to unmask]
Mathew Hogan
Senior Consultant
Pharmaceutical, Biometrics & CRO Division
1st Pharma People
A Division of 1st-IT People
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
mailto:[log in to unmask]
<mailto:[log in to unmask]>
www.1st-pharmapeople.com <http://www.1st-pharmapeople.com/>
PLEASE NOTE: As of 31st May 2005 our office address will change to; 1st IT
People, 3rd Floor, Woolverstone House, 61-62 Berners Street, London. W1T
3NJ. As a result of this, we do have a new telephone number of 0207 255
6665. Please note our previous phone number will still work.
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