Principal Statistical Programmer

Company
Cytel
Location
Germany (DE)
Salary
Eur- 80,000.00 - 85,000.00
Posted
28 Jan 2021
Closes
27 Feb 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

As a Principal Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. 

 

  • Must have Oncology TA experience
  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
  • Applying your CDISC know-how and proficiency in Safety and Efficacy ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
  • Generating complex ad-hoc reports
  • Preparing and validating submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21
  • Applying your strong understanding/experience with Efficacy analysis;
  • Preparing submission packages
  • Performing lead duties when called upon;
  • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change

 

Qualifications and Experience:

 

  • BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Must have relevant industry experience
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Ability to implement the latest CDISC ADaM standards (production/validation). ADaM efficacy dataset development is required.
  • Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
  • Proficiency in SAS  MACRO development
  • Strong ad-hoc reporting   
  • Solid experience in Efficacy analysis
  • Experience and or familiar with Pinnacle21
  • Submissions experience utilizing define.xml and other submission documents such as SDRG, ADRG
  • Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease are strongly desirable. Oncology knowledge of efficacy endpoints is also desired. 
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

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