Senior Biostatistician/Biostatisticien(ne) sénior

Description du poste et des missions

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

Profil souhaité

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).

Compétences requises

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

Lieu de la mission