Manager, Biostatistics - (Un-MD-Rockville - 20859)

Minimum Education: Doctorate
Jobcode: 257413
Email this job to yourself or to a friend | Job Match Test | Resume Guide

Provides statistical input in the clinical development plan and protocols and conducts statistical analyses to support Clinical Study Reports (CSR) and other regulatory documents (e.g., integrated efficacy and safety summaries, etc.) to help advance the drug development process and accurate labeling. MAJOR PHARMACEUTICAL COMPANY in ROCKVILLE, MDIn their Tuberculosis Unit If we send resume- we will get feedback from HR within Hour And then phone interview with him and hiring manager within 24 hours. Then FF and offer within 48 hours (then pre-smployment screen takes 7 days and then can start )They are in Phase II and IIIB study PREPARING for an NDA in 2010Therapeutic area is not necessary but industry experience is! (Since no studies have been in done in TB in 40 yrs if you had to look for a TA related- he said Infectious disease or Chronic diseas- but AGAIN ther expertise not important)This position is EITHER a Snr Biostat or Manager, Biostat (see 2 job descript attached)They will RELOSalary for Manager is 113k with 10% bonusAnd for Snr Biostat is about 90-100k, with 10% bonusJob Responsibilities10% Takes full responsibility in managing all Biostatistical tasks for one core project. 10% Provides technical direction to contracting statisticians and subject area experts working on projects 10% Provides statistical input to clinical development plans (CDP)10% Provides statistical analysis plan including study design, sample size, primary and secondary endpoints and statistical analysis method. Reviews protocol outlines and protocols.10% Develops final tables and listings (and figures) for final study report (FSR)? Develops Table of Contents (TOC) and Tables & Listings templates? Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations? Provides specs to SAS programmers for generating analysis datasets? Programs efficacy analysis and produce final efficacy tables and figures? Reviews final tables, listings, and figures. 10% Develops tables and listings (and figures) for other regulatory submission? Performs statistical analyses for PK/PD parameters? Provides safety tables and listings for IND annual reports and PSUR? Provides tables and listings for FDA meeting briefing packages? Performs exploratory analyses? Performs statistical analyses for marketing and Phase IV studies? Performs statistical analyses for abstracts, posters and publications10% Works on NDA submission? Provides Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety ISS) tables? Reviews ISS and ISE reports? Prepares briefing packages for FDA Advisory Meetings? Participates in responding to Advisory Committee questions in NDA defense. 5% Produce Randomization codes5% Review CRF5% Review and approve database structure and edit-check specifications5% Review and other clinical documents such as clinical operation manual, investigator brochure (I ), etc.5% Develops of final study report (FSR)? Provides Statistical Methods section? Summarizes Efficacy Results? Reviews FSR5% FDA contracts and regulatory meetings? Draft response to questions from regulatory agencies? Participate in preparing FDA briefing packages? Attend meetings with Regulatory AgenciesKnowledge, Skills, and CompetenciesKnowledge Understands the companys products, the competition, and the pharmaceutical industry in general. Demonstrates a competent knowledge of the companys work tools, processes, and policies. Maintains a current awareness of new drug developments and statistical methodologies in the business. Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. Skills In-depth knowledge of statistical principles, applications, and SAS programming software. Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Knows how/when to apply organizational policy or procedures to a variety of situations.Competencies Adaptable Adjusts readily and effectively to frequent changes in the work, processes, and requirements of the position; tries to understand change and quickly adjust focus and behavior; able to adjust to new leadership, new ways of doing things, and new priorities. Building effective partnerships and work relationships Uses appropriate interpersonal styles and communication methods to build and support effective working relationships with internal groups, global affiliates, and external groups; cultivates an active network; establishes and/or supports shared goals; reduces barriers between people, units, and/or locations; fosters open dialogue and effective communications; negotiates for an acceptable outcome. Strong oral and written communication and presentation skills Clearly conveys information and ideas to individuals and groups (internal and external); makes it a point to communicate regularly to peers, team members, subordinates, and/or managers; effectively organizes