Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Manager - Statistical Programming - Medical Device - UK

Company: Umbilical Life
Location:
Reference: JC73
Closing Date: 01 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

James Carrera of Umbilical Life is recruiting a Statistical Programming Manager to work with a Multi-Site Medical Device business. Call James on 0044 116 461 0070 or email james.carrera@umbilical-life.com

Requirements:

Responsibilities:

  • Attend multidisciplinary team meetings, representing the programming function.
  • Create or review and approve programming plans at study and project level.
  • Provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
  • Create or review and approve CDISC compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
  • Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
  • Assist statisticians by suggesting algorithms to address novel analysis requests
  • Develop software validation procedures and test plans, as necessary.
  • Create and document archives of software, outputs, and analysis files.
  • Create and maintain department SOPs related to clinical programming.
  • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
  • Oversee work of internal contract programmers and external vendors.
  • Provide time and resource estimates for project planning.

 

 

Qualifications:

  • Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields Master’s Degree preferred
  • 7 years of experience in developing software for clinical trials using the SAS system
  • Skilled in programming with SAS. Knowledge of additional programming languages a plus.
  • Good knowledge of statistics and drug development process
  • Experience as a lead programmer for NDAs/BLAs
  • Experience in pharmacokinetics/pharmacodynamics modelling a plus
  • Familiarity with CDISC standards, including SDTM and ADaM models
  • Solid verbal and written communication skills

 

Benefits:

As well as a competitive salary you will receive outstanding industry benefits including pension, life and medical insurance, car allowance etc.

 

For a confidential discussion please contact James Carerra at Umbilical

on +44 (0) 116 461 0070 or email james.carrera@umbilical-life.com

Apply for this job: Manager - Statistical Programming - Medical Device - UK

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.