Job Listing: Bio statistician

Manager Bio statistics

JOB DESCRIPTION

The Manager of Bio statistics is the lead for the bio statistics skills group in their location. The position works in close collaboration with Head of Bio statistics, Manager NA SAS Programming, Heads of Clinical Development, Heads of Clinical Operations and Clinical Team Leaders, to allocate named resources to development projects.

JOB RESPONSIBILITIES

Leads the bio statistics skills group in local department, including line management, coaching, mentoring and appraisal for staff and cascades information to North American platform members. 20%

Maintains close and effective interactions with Manager of NA SAS Programming, Heads of Clinical Development and Clinical Team Leaders. 20%

Works with Head of NA Bio statistics, Manager of NA SAS Programming, Heads of Clinical Development, Heads of Clinical Operations and Clinical Team Leaders to allocate named resources to development projects based on project milestones and priorities communicated by the Project Team Leader. Informs Head of NA Bio statistics regarding under or over re sourcing issues. 10%

Works with Head of NA Biostatistics, Manager of NA SAS Programming, Heads of Clinical Development, Heads of Clinical Operations and Clinical Team Leaders to allocate named resources to development projects based on project milestones and priorities communicated by the Project Team Leader. Informs Head of NA Biostatistics regarding under or over resourcing issues. 10%

Monitors external developments for impact on internal working practices. 10%

Defines, develops and implements standards (process), tools and procedures for the biostatistics platform skill set within the Company to ensure clear definition of the nature and quality of outputs across projects. Works with European counterparts to harmonize processes. 10%

Reviews and provides needed information for the development of statistical analysis plans for Clinical Studies. 10%

Other duties as assigned by Manager 10%

May represent the Biostatistics function concerning clinical projects at meetings with Regulatory agencies. 5%

Approves resource allocation proposals for the Local Platform. 5%

TECHNICAL DATA

The technical/functional environment is the biostatistics platform within Clinical Development in North America. Close and effective interactions with Head of Biostatistics, other NA Clinical Development Platform Heads, Manager of NA SAS Programming, Heads of Clinical Development and Clinical Team Leaders are critical interfaces. Provides critical input on the design and analysis of clinical protocols. Works closely with the Head of NA Biostatistics, Manager of NA SAS Programming, and other NA Clinical Development Platform Heads to improve work processes and create efficiencies between the platforms. Ensures the quality of all deliverables for Biostatistics and the clinical teams.

The incumbent approves resource allocation proposals for biostatistics in North America, and together with Head of NA Biostatistics, Manager of NA SAS Programming, Heads of Clinical Development and Clinical Team Leaders, allocates specific resources to development projects.

Qualified candidate will have experience in clinical trials 1-4 and with filing
NDA's and BLA's. Experience in Pharmaceutical or Vaccines industry a must.

Required Skills for Bio statistician Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.