Dear Allstat, 

Please find below our latest European Permanent SAS Vacancy for a Global
Pharma based in Europe.  

If this position is of interest to you and would like more information
please send an updated CV to [log in to unmask] or alternatively
call me +44 (0)207 922 7126

Key Points

- Our clients are seeking a Specialist Principal statistical programmer with
some knowledge/experience of Pharmacoeconomic modelling. 

- This role is a full time on-site role with an excellent remuneration
package and relocation offered. 

- Ideally experience in programming on large data bases and a strong
statistical background. 

- Ideally working experience in epidemiology and basic knowledge in
epidemiological methods. 

- Exciting opportunity to work for a Global Pharma in a niche area. 

Description

- Lead and support worldwide statistical programming activities for assigned
project area, for clinical trials whose responsibility resides in
Development.

- Function as lead statistical programmer or support programmer with respect
to all statistical programming activities for multiple clinical trials or
submissions. Set-up and oversee a clinical project or trial, and provide
programming support to enable delivery of high quality statistical
programming work product. Generate datasets (SDTM and ADaM) and tables,
figures, listings, and documentation for clinical study reports, ad hoc
requests, and regulatory submissions.

- Collaborate and Interface with project and clinical trials teams and other
departments assigned to ensure delivery of high quality statistical
programming services and work product.

- Provide input on and ensure respect to agreed deadlines for projects
assigned.

Major Accountabilities

- Provide expert levels of effective Collaboration for statistical
programming initiatives with departments within Global Data Operations, and
outside Global Data Operations (Global Biostatistics, Global Health Outcomes
Research, Global Medical Writing, New Medicines, Global Clinical Operations,
Therapeutic Areas, Global Medical Affairs and Affiliates) to facilitate
understanding of statistical programming services and work product.
Represent Global Statistical Programming to support this activity.

Standard Accountabilities

- Program, validate, maintain, and document statistical analysis programs
for clinical trials on the basis of the Statistical Analysis Plan and of
other trial documents (Protocol, CRF, DMM) following standard operating
procedures and working documents.

- Ensure that submission and trial datasets (SDTM and ADaM), tables,
figures, listings, statistical output, and program documentation meet
standards requirements of regulatory agencies and other departments
 
- Ensure that datasets, tables, figures, listings, and statistical outputs
are produced in an efficient manner, following Global Statistical
Programming procedures and standards. Assist with developing specification
documentation for datasets (SDTM and ADaM) , pooled datasets, tables,
figures, listings, and associated metadata.

- Support direction, motivation, and oversight of statistical programming
resources (internal and external) for timely delivery of all statistical
programming deliverables. Mentor other statistical programmers as
designated.

- Support development and rollout of new standards and processes with
respect to own statistical programming operations team.

- Ensure compliance with the 21-CFR Part 11 regulations in terms of
validation of SAS programs used for the purpose of statistical reporting of
clinical studies.

Requirements

Education: MSc Degree required ideally in a statistical discipline

Experience:

- Strong experience in Statistical Programming within the Biotechnology
and/or Pharmaceutical Industry, including clinical research organizations.

- Experience in a multicultural and global pharmaceutical environment.

- Experience with statistical programming aspects required for regulatory
submissions.

If this position is of interest to you please send an updated CV to
[log in to unmask] or alternatively call me +44 (0)207 922 7126


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