As a Senior Biostatistician you will be providing statistical expertise to clinical project teams, following procedural frameworks within GE HealthCare pharmaceutical business.
Principal responsibility of clinical development under the R&D at GE HealthCare PDX (Pharmaceutical Diagnostics) is to manage the clinical trials aiming at demonstrating the efficacy and safety of pharmaceutical products (eg. Contrast media, molecular imaging tracers), contrary to GE HealthCare MS (Medical system) which is responsible for the Medical devices (eg. Scanners, MRI or ultrasound..).
As part of R&D, the biometry group is in charge of the management of data collection, cleaning and reporting of the clinical trial data from various phases (1 to 4) as well as the constitution biometry components of eCTD (eg. CDISC package) for regulatory submission and approval.
Job Description
Duties include (but are not limited to):
- Formulate statistical objectives, experimental designs and statistical analyses for research projects
- Oversee outsourced activities
- Author/Review statistical analysis plans (SAP) ensuring study objectives defined in the study protocol are followed
- Review CRFs, mock shells, programming specifications to ensure consistency with protocol and SAP
- Write programming for advanced statistical analyses using commercial software
- Validate statistical procedures and perform quality assurance checks for statistical analyses and reports
- Review and validate STMD and ADaM packages (including aCRF, Pinnacle report, Define.xml, Reviewer’s guides and all related documents)
- Ensure the eTMF is maintained up to date
- Represent statistics department on assigned project
- Work with team in the development of project timelines
- Ensure our biometric partner is achieving our KPIs across projects
- Contributes to biometry process improvement
Quality Specific Goals:
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
- Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
Qualifications:
- MS or PhD in Statistics or related fields
- MSC with ≈10 years or PhD with ≈7 years of experience or equivalent in a biostatistics department within a CRO, a pharmaceutical company or a biotech.
- Solid knowledge of CDISC and regulatory guidance (eg. ICH)
- Advanced knowledge of SAS.
- Working knowledge of other software/applications (PASS, R, S-plus, East).
Required skills:
- Skills in written and verbal presentation of statistical results
- Solid interpersonal and leadership skills
- Track record of project management for biostatistics activities
- Skills in solving problems
- Excellent knowledge of industry standard (ICH, CDISC)
Preferred skills:
- Prior experience and/or knowledge in adaptive design
- Ability to summarize and popularize statistical problematics.
- Track record of involvement in regulatory dossier submission
- Knowledge in diagnostic studies is a plus
- Working knowledge of English, working knowledge of French is a plus
Work model : Hybrid
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
