Senior Biostatistician (Nutley, NJ)

Our client is a contract research organization that provides statistical, data management, clinical trial monitoring and medical writing services to pharmaceutical and biotechnology companies. They require an experienced Biostatistician to work on-site for a major Pharmaceutical client in Nutley, New Jersey. As a core member of the Study Management Team (SMT), the Senior Biostatistician will provide expertise and statistical leadership to enable effective decision making for the assigned clinical trial project.,and will be responsible for all statistical activities within a project ensuring that these activities are performed according to quality, timeline and cost requirements defined by the SMT. PRINCIPAL RESPONSIBILITIES include: • Providing overall strategic direction and leadership for statistics on a clinical project. • Ensuring project statistical standards are agreed within the trial sponsor company, documented, and implemented throughout the project. • Responsibility for the development and communication of statistical project plans, including timelines/milestones, staffing requirements, general requirements for statistical analysis planning, execution, quality control and assurance, statistical reporting, and archival of statistical programs, outputs, and documentation. • Providing input to protocol development to ensure that sound statistical methodologies are employed in the trial design and sample size calculation, and appropriate statistical analysis approaches are defined in the protocol. • Providing input to CRF development to ensure overall consistency within the project and compliance with the global standards. • Working with statistical CRO to prioritize statistical and programming tasks when timeline and resource conflicts occur. • Participating in discussions and resolution of critical issues. • Ensuring that project specific statistical procedures are defined and disseminated to the relevant clinical trial functional teams. • Initiating/coordinating global meetings for a clinical project to establish communication, and identify and resolve issues in planning, resource allocation, and technical areas. • Acting as a liaison between statistical function and all other relevant functions for the project. • Following up on the project timelines and deliverables with the CRO statistical team, resolving any issues that may arise during the trial. • Maintaining knowledge of current global regulatory guidelines relevant to clinical trial biostatistics, as well as related SOPs, guidelines and Best Working Practices of the trial sponsor. • Working with CRO Biostatistician for presenting at clinical investigator meetings and results dissemination meetings. • Participating in and contributing to clinical trial statistical initiatives. • Contributing to the selection and evaluation of CROs. • Providing direction and sponsor’s statistical expertise to CROs as required. •

Required Skills:

A PhD degree or equivalent in Statistical Science, Mathematical Analysis or related field or Masters degree • PhD plus 3 years relevant experience with demonstrated ability and sustained performance. • Master’s degree plus 6 years relevant experience • Experience with SAS, Statistical sample size calculation software

Desired Skills:

Experience with Microsoft Word, PowerPoint, Excel, Outlook. • Effective communication skills, oral and written. • The ability to work in a multi-disciplinary team setting.

For this role you will be working on-site at a major pharmaceutical client and be exposed to new global projects. The company is offering an excellent salary of between $100,000 – 120,000 depending on experience. For applications or further information please email your CV to: christopher@fforde-management.com quoting ref SAS 00066, or telephone our specialist consultant, Chris Sauls, on +1 212 520 8304 who will be pleased to advise you on your personal career needs. Alternatively you may write to us at 2nd Floor, 825 Third Avenue, New York, NY 10022 or Fax: 212-520-8501 Fforde is a uniquely specialised recruitment agency for the pharmaceutical, clinical research and biotechnology sectors. We pride ourselves on a glowing reputation within the industry and a high-quality personalised service dedicated to intelligent delivery. Explore our website and see all our job opportunities. www.fforde-management.com

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