Statistician needed in MD!!

 Title:  StatisticianLocation:  Gaithersburg, MD Job Description: Biotech company in MD is looking for a Clinical Statistician  A successful candidate is expected to provide statistical support to enable effective and efficient development of the investigational therapeutic agent. He/she will be responsible for all statistical activities within assigned clinical trials, operating with appropriate supervision of the Therapeutic Head and other Senior Statisticians.   Responsibilities: · Manage and review statistical related work from CROs, including protocol, SAP, tables, listing and graph reviews. · Create statistical sections for study synopses and protocols.  · Create statistical documents including CRF specifications document, statistical analysis plan, and statistical programming plan with templates for tables, listings and graphs, etc. · Support the preparation of regulatory submissions (e.g. BLA, NDA, briefing documents, and responses to FDA requests).  · Represent Biostatistics in project team meetings and other project activities. · Design and validate analysis data sets, SAS programs and study report tables.  · Perform statistical analyses, generate reports and create statistical text for study reports, clinical publications and other communications.  · Design data error check algorithm and perform the error check.  · Present statistical considerations at investigator or other external meetings. · Participate in the preparation, review and approval of IVRS specification, case report forms, and data edit spec.  · Participate in intra-department teams for specific statistical research/task.  · Present statistical topics at the internal Biostatistics meetings. · Contribute to the development and review of SOPs and other controlled documents in the biostatistics department.  · Contribute to the departmental process and infrastructure activities.  · May also participate in providing statistical support/strategy for post-marketing/Medical Affairs activities.   Qualifications: MS or Ph.D. in Statistics or a related field with a minimum of 3-5 years of Biotech or Pharmaceutical industry or CRO experience.  Must have comprehensive knowledge of applied statistical principles and modeling in the design and analysis of clinical trials and proficiency in statistical software such as SAS and StatXact.  Must have excellent interpersonal and effective verbal and written communication skills.   If you are interested in this opportunity and have the qualifications, please email your resume to: tloaiza@smithhanley.com    Education:Master's Degree Reference Code:3020522