OB TITLE: STATISTICAL PROGRAMMING SENIOR MANAGER
SUMMARY OF ROLE: Our client, a major global Pharma, requires a Senior
Manager of Statistical Programming at their UK office in Hertfordshire.
The role holder will support the Biostatistics team by carrying out and
overseeing programming activities to ensure timely and accurate
programming and validation activities for clinical studies. As a senior
member of the team he/she will contribute to the overall efficiency and
best practice running of the Biostatistics group, demonstrating the
ability to work efficiently and to a high standard within a clinical team
environment.
CLIENT INFORMATION: The UK subsidiary of a company that discovers,
develops and markets pharmaceutical products around the world. They are
an innovative, efficient and firmly solution oriented pharmaceutical
company whose aspiration is to become the number one global provider of
healthcare solutions. Drawing on the R&D strengths of the global parent
company they focus on four main therapeutic areas - neurology,
gastrointestinal disorders, oncology and acute care. They have had a UK
presence since 1988 and now have offices around Europe.
PRINCIPAL RESPONSIBILITIES include:
· Overseeing and managing programming activities conducted by
external vendors (e.g., CROs), supervising Programmers (e.g., Statistical
Programmers) and their activities including assignment of projects.
· Working with external vendors in order to develop or monitor the
content and structure of SAS data sets.
· Working closely with project Statisticians to ensure related
timelines are met for producing analysis data sets, tables, listings and
graphs for clinical study reports, maintaining standards for programming
activities.
· Providing statistical programming and validation support for
clinical study reports to achieve timely progress.
· Developing and maintaining SOPs, SWPs and other related technical
documents.
· Providing input to the Database and CRF Development.
· Providing input in developing statistical analysis plans,
specifications of analysis datasets, validation plans, and other related
documents.
· Determining and researching SAS software upgrades and related
system maintenance issues.
· Pursuing individual professional development and continuing
education opportunities.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
· Bachelor's degree in Statistics, Computer Science, Mathematics, or
a related science discipline.
· Masters degree preferred.
· Relevant experience in SAS programming for phase I-IV clinical
trials in a pharmaceutical/CRO environment.
· Some management experience in a pharmaceutical/CRO programming
environment or demonstrated significant leadership of SAS programming
activities in a clinical pharmaceutical/CRO environment
· Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
· Proven experience with Unix and Windows operating systems.
· Understanding of the software development life cycle.
· Understanding of FDA guidelines.
· History of working in complex team environments with
numerous/diverse stakeholders.
SKILLS & PERSONAL ATTRIBUTES:
· Strong verbal, written and interpersonal communication skills.
· Good organization, time management and attention to detail skills
· Ability to work in a stressful environment under tight deadlines
while maintaining focus on details and quality.
· Applies good judgment and leads problem solving within the team.
BENEFITS OF THE ROLE: This is a senior role of key importance for a
company that recognises their employees as being their greatest asset.
They have made a commitment to provide a competitive compensation
programme that will attract and retain the talent they need. You will be
rewarded for your excellence in work performance with a very competitive
salary, eligibility to participate in annual incentive rewards and a
comprehensive benefits package.
For applications or further information please email your CV to:
[log in to unmask] <mailto:[log in to unmask]> or
telephone our specialist consultant, David Heath, on +44 (0)1273 222961
who will be pleased to advise you on your personal career needs.
Alternatively you may write to us at Curtis House, 34 Third Avenue, Hove
BN3 2PD or Fax: +44 (0)1273 325350.
www.fforde-management.com
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