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.
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.
- 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.
- 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.