SENIOR BIOSTATISTICIAN / STATISTICIAN

SENIOR BIOSTATISTICIAN / STATISTICIAN

Everest Clinical Research Services Inc. (“Everest”) is a contract research organization providing statistical, data management, clinical trial monitoring and medical writing services to pharmaceutical and biotechnology companies. We serve some of the best-known companies worldwide, and work with many of the most advanced drugs in development today. We are in a major growth mode with several openings for experienced Biostatisticians in our Northern New Jersey office.

 

If you want to be involved with major pharmaceutical and biotech firms, participate on major drug development studies, be a key member of an expanding company, work in a relaxed and wonderful environment then Everest is the place for you.

 

Basic Job Functions:

 

As a core member of the Study Management Team (SMT), the Biostatistician provides expertise and statistical leadership to effectively enable decision making for the assigned clinical trial project. The Biostatistician is responsible and accountable for all statistical activities within a project and assures that these activities are performed according to quality, timeline and cost requirements defined by the SMT.

 

Key Accountabilities:



 

· Provides overall strategic direction and leadership for statistics on a clinical project.

· Ensures project statistical standards are agreed within the trial sponsor company, documented, and implemented throughout the project.

· Responsible 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.

· Provides 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.

· Provide input to CRF development to ensure overall consistency within the project and compliance with the global standards.

· Works with statistical CRO to prioritize statistical and programming tasks when timeline and resource conflicts occur.

· Participates in discussions and resolution of critical issues.

· Ensures that project specific statistical procedures are defined and disseminated to the relevant clinical trial functional teams.

· Initiates/coordinates global meetings for a clinical project to establish communication, and identify and resolve issues in planning, resource allocation, and technical areas.

· Acts as a liaison between statistical function and all other relevant functions for the project.

· Follows up on the project timelines and deliverables with the CRO statistical team, resolves any issues that may arise during the trial.

· Maintains 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.

· Works with CRO Biostatistician for presenting at clinical investigator meetings and results dissemination meetings.

· Participates in and contributes to clinical trial statistical initiatives.

· Contributes to the selection and evaluation of CROs.

· Provides direction and sponsor’s statistical expertise to CROs as required.

 

Qualifications and Experience:

 

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 3 years relevant experience or a master’s degree plus 6 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level. Must communicate effectively, orally and in writing. Ability to work in a multi-disciplinary team setting.

 

Experience with Key Software:

 

· Microsoft Word, PowerPoint, Excel, Outlook

· SAS, Statistical sample size calculation software

 

Various positions are available (www.ecrscorp.com). Candidates will be considered according to qualifications and years of experience. Resumes should be sent to careers@ecrscorp.com .

 

We are an equal opportunity employer. We thank all interested applicants, however, only those selected for an interview will be contacted.