Job Category: Accounting

Associate Director Biostatistics (DG)

Job Location: Remote

Date Posted: 2021-02-09

Associate Director Biostatistics (DG)
(remote or onsite)

The Associate Director of Biostatistics may act as project statistician and is responsible for ensuring oversight and consistency cross more trials within one or more development projects. The Associate Director of Biostatistics may also act as biostatistician on clinical trials and will be part of the Clinical Management Team (CMT)/Compound Development Team (CDT). As biostatistician on a trial the Associate Director will be responsible for carrying out trial related activities or overseeing these including planning, analysis, reporting and publication and participate in other trial related activities. The Associate Director may provide input to clinical drug development programs, and be responsible for reviewing and providing input to the Clinical and Compound Development Plans developed by the CDT on one or more projects and participates in meetings with Key Opinion Leaders (KOLs) and regulatory authorities. The Associate Director may represent Clinical Operations in Project Boards, Global Development Teams, Safety Committees and Operational Committee’s/Steering Committee’s with the partners and or vendors. The Associate Director will also give input to the department related activities, the overall department strategy and lead/support various initiatives/activities internally within the department or across departments. You will be reporting to Head of Biostatistics, who is located in the US. As an Associate Director in Biostatistics, you will be a part of the Biostatistics team in DK and US and work closely with the clinical management team. You will also be an active member of the Global Project Team.

Your key responsibilities include but are not limited to:
Develops and maintains expert competences within statistical analysis, modelling and simulation and advanced trial designs. Contributes to the profiling of the company, as highly scientific and specialized within the area of oncology. Represents company during meetings/congresses and courses and perform professional networking. Follows scientific and technical progress within the field of biostatistics in drug development and provides advice on new methodologies that may support innovation and improve efficiencies. Engages with regulatory authorities. Contributes to clinical development plans. Provides statistical input to trial designs, synopses and protocols. Ensures biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports. Arranges/attends lessons learned to share learnings. Represents Client during KOL meetings. Acts as a role model. Proactively engages in department activities. Leads various initiatives within the department. Proactively contributes to support a global organization. Acts as mentor for new employees or consultants.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

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