Biostats Specialist CELGJP00002840
Berkeley Heights, NJ
Responsibilities will include, but are not limited to, the following:
Work under the direction of Medical Affairs Statistics Disease Lead.
Actively provide statistical support to the Medical Affairs Department.
Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes data mining, meta-analysis, and support for data-driven analyses.
Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters.
Provide statistical reviews of proposed design and analysis of protocols for investigator initiated trials.
Provide statistical input for design, sample size and protocol for Medical Affairs studies.
Provide review of statistical analysis plan including table shells, analysis dataset specifications and all deliverables for Medical Affairs studies provided by CRO.
Manage outside CROs and consultants as needed.
Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.
•Masters in Statistics with a focus on statistical methods appropriate for clinical trials is essential. Ph.D. in statistics optional.
• Minimum of 3 years of solid experience and demonstrated skill in the planning, analysis and reporting of clinical trials.
•Oncology experience is a plus.
•Good planning and project management skills.
•Detailed knowledge of currently acceptable statistical methodologies.
•Excellent SAS skills including report generation. Willingness to be hands-on when needed.
•Knowledge of MS Office products (Word, Excel, PowerPoint).
•Excellent communication, writing and organizational skills is essential.
•Demonstrated ability to work in a team environment with clinicians, clinical monitors, data managers, programmers and medical writers.