Hello Allstat,

 

SEC Pharma is currently recruiting for a contract Statistical Programmer to work for a leading organisation in the UK.

 

In this role you will be responsible for providing support to the Biostatistics team by production and validation of statistical programmes in CSRs, integrations, submissions, exploratory analysis and regulatory submissions. You will also be contributing to the efficiency and best practices of your working group working to the highest possible standards.

 

This Pharmaceutical Company has a global reputation for excellence and is at the forefront of the latest technology and practices. Their offices just outside of London are state of the art and you will also be working in a comfortable and relaxed matrix team environment. There is an element of team management involved in this role and you will typically be reporting into Associate Director or above.

  

Your accountabilities

 

-          Produce and validate high quality statistical programming deliverables (SDTMs, ADaMs, Tables, Listings and Graphics)

-          Support objectives, policies and operational targets that have a direct impact on the work unit or operational outcome

-          Execute work procedures in a project context.

-          Have direct contact with clients and external vendors and troubleshooting routine client inquiries.

-          You will direct the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees

-          You will review SAP, TLG shells and variable derivation rules and provides feedback

-          Review Study Quality Surveillance Plan and  Data Monitoring Committee charter

-          Implement the monitoring plan set by the statistician and produces the needed datasets and TLGs

-          Ensure data quality and report data issues to DM on timely basis and track resolution

-          Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific datasets

-          Develop programs for the creation and validation of datasets (SDTM & ADaM) and TLGs.

-          Supports ad-hoc, interim, exploratory, publications and performs programming and generates outputs

-          Maintain data, programs and reports in accordance with 21 CFR part 11

-          Creates / validate the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)

 

Your skill set

 

-          Experience in clinical development statistical programming methods and processes in industry setting required Experience with SDTM & ADaM in Oncology including with report submissions

-          SAS – BASE, MACRO, SQL, STAT, GRAPH

-          Knowledge of the software development lifecycle

-          Understanding of FDA guidelines

-          Strong communication skills, proactive professional approach

 

If you would like to apply for the position or wish to learn more about the role and company please call Priya Mukherjee on 0044 (0) 207 255 6665 or email your CV with a brief covering note to [log in to unmask]

 

SEC are a Recruitment and Employment Confederation member and ISO9001:2000 accredited specialist recruitment organisation working within the Pharmaceutical, Biotech and CRO industries. If you are interested to learn more about further appointments within Clinical Data Management across the UK and mainland Europe contact Mark on 0044 (0) 20 7 255 6665 for a confidential discussion.

 

SEC Recruitment Limited is acting as an Employment Agency and or an Employment Business

 

Priya Mukherjee Principal Consultant

Tel:   +44 (0)20 7255 6655  Fax:   +44 (0)20 7255 6656 Mobile:   +44 (0)7717578256 Email:   [log in to unmask] Web:   www.secrecruitment.com