Statistical Programmer

Job description

For the expansion of our client's clinical team, we are looking for a Statistical Programmer.

The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Their unique antibody engineering technologies combined with the complementary expertise of their people enables them to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.

Responsibilities

The Statistical Programmer is responsible for all statistical programming activities. These responsibilities include:

  • Provides relevant input in the development of the CRF, statistical analysis plan and mock tables, listings and figures.
  • Performs critical review of derived datasets specifications and derived datasets (ADaM).
  • Develops programs to perform QC of statistical outputs.
  • Defines program specific standards for ADaM datasets. Checks compliance of CRO delivered ADaM datasets to CDISC standards.
  • Verifies define.xml (for ADaM’s).
  • Programs, validates or performs QC on the NONMEM dataset.
  • Develops, validates and documents programs for additional post-hoc analyses.
  • Develops, reviews, documents and performs validation of generic SAS macros, and creates a macro library.
  • Participates in project team meetings.
  • Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE).
  • Supports outsourcing programming activities and oversees the QC of these activities.
Profile
  • Expertise with diverse statistical software packages such as SAS and R. Experience with EAST or Winbugs is a plus.
  • Thorough knowledge of and experience with CDISC standards is desired.
  • Demonstrates ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).
  • Displays good communication skills and proficiency to work independently and as part of a team.
  • Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development.
  • Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
  • Excellent knowledge of SAS and R is a must.
  • Minimum of 3-4 years of professional experience desired.
  • Experience in managing CROs and vendors is a plus.
  • Biotech experience is a plus.  
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Location
Gent
Contact person

Tim Janssen

Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46
tim.janssen@fern-valley.com