Key Accountabilities/Responsibilities:

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

• Provides relevant input in the development of the 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) and ADRG.
• 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.
• Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE).
• Supports outsourcing programming activities and coordinates the QC of these activities.
• Can assess well time needed for all programming related activities.
• Is able to independently handle programming activities for 1 or 2 studies and integrated summaries within 1 project simultaneously.
• Take ownership to deliver a project in time.
• Is able to negotiate timelines and can assess when extra resources are needed and is able to communicate this in time.

Desired Skills and Experience:

• Excellent knowledge of SAS is a must. Knowledge in R is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan and complete 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.
• Minimum of 8-10 years of professional experience desired.
• Experience in handling CROs and vendors is a plus.
• Biotech experience is a plus.

Key Accountabilities/Responsibilities:

The senior Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:

• Serves as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
• Contributes to clinical study synopses and protocols.
• Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
• Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
• Provides relevant input in the development and review of CRFs.
• Performs lead review and sets up internal QC of TFLs.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Contributes to clinical study reports.
• Reviews simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.
• Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
• Contributes to press releases and scientific papers.

Desired Skills and Experience:

• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Proficient with other statistical software such as R, EAST, Winbugs is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Displays excellent communication skills with proven leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.
• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience desired.
• Experience in handling CROs and vendors is a plus
• Biotech experience is a plus
• Auto-immune and/or oncology clinical study background is a plus