JOB TITLE: - STATISTICAL PROGRAMMER, BU Oncology, based in
Switzerland - Ref FW 10620
SUMMARY OF ROLE: Statistical Programmer required by world leading
pharmaceutical company based at the Swiss/French border. Successful
candidate will manage the programming activities for a global project
while acting as Programme Programmer for assigned projects and taking a
programming leadership role on the B&SR project team.
CLIENT INFORMATION: Our client is a pharmaceutical giant, ranking in the
world's top 5 in this industry. It operates in 140 countries through 360
independent affiliates, while offering a range of pharmaceutical products
and services within primary care, oncology, transplantation, ophthalmics
and mature products. In its consumer health division, it deals primarily
with OTC drugs, animal health, medical nutrition, infants and babies. In
2003, its group sales increased by 19%, taking this market leader from
strength to strength. A generous benefits package is available.
JOB ROLE: Working within the functional area of Development you will:
§ Manage the programming activities for a global project following
internal project management guidelines including resource planning.
§ Act as Program Programmer for assigned projects and take a
programming leadership role on the B&SR project team.
§ Maintain efficient interfaces with internal and external customers
with advice from SR management.
Develop and comply with project / study standards and specifications
following internal and regulatory guidelines.
§ Oversee programming style, quality of SR contributions and
compliance with timelines.
Provide SR input and lead sections of Full Development and Submission
Working Groups.
§ Ensure that documents and specifications are consistent and comply
with company standards by providing input into study protocol, CRF and
data structures.
§ Program, according to specifications, analysis datasets, pooled
datasets, listings, summaries, figures and tables for phase I-IV clinical
trials and for SCS and SCE.
§ Ensure quality control and quality audit of deliverables.
§ Maintain records for all assigned projects and archive trial /
project analysis and associated documentation.
§ Participate in the selection of CROs, as required, and supervise
SR project activities for CROs.
§ Train staff on trial and project level activities and internal
processes.
§ Participate in or lead non-clinical project activities.
MINIMUM REQUIREMENTS:
Ø Minimum of a BA/BS or equivalent experience in mathematics,
statistics, computer science or life sciences or related field(s) or MS
Statistics.
Ø Expert knowledge of / experience with SAS software.
Ø Good understanding of global clinical trial practices, procedures,
methodologies.
Good understanding of regulatory requirements relevant to SR (e.g. GCP,
ICH).
Ø Experience in providing recommendations for maintenance or
development of SR global policies, procedures and clinical data
presentation standards.
Ø Intermediate knowledge of office tools.
Ø At least 8 years experience in a programming role preferably
supporting clinical trials/ or in the pharmaceutical industry (5 years for
MS Statistics / Computer Science)
BENEFITS OF THE ROLE: This is an excellent opportunity to join one of the
world's pharmaceutical leaders in a culture where professional flair and
high standards are recognised and generously rewarded. This company is
well-known for its significant benefits package; its name on your CV would
provide polish to your track record of excellence, while living in the
Swiss/French border region within driving distance of France, Austria,
Germany and Italy holds lifestyle promise.
KEY WORDS: STATISTICS / STATISTICIAN / STATISTICAL PROGRAMMER /
PROGRAMMER / STATISTICAL REPORTING / SAS / SAS PROGRAMMING / SAS
PROGRAMMER / CLINICAL TRIAL / REGULATORY / ONCOLOGY
Fforde specialises in the supply of staff within the Pharmaceutical, CRO
and Biotechnology sectors.
<http://www.fforde-management.com>
Email your CV to: [log in to unmask]
Speak to: Den Lowpetch on 01273 722366
Or write to us at Curtis House, 34 Third Avenue, Hove BN3 2PD
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