| Manager, Biostatistics |
Job Id: W257413 |
Posted On: 11/25/2009 |
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Location: Rockville, MD;
Job Type: Full Time
Salary: $100000.00 to $113000.00/year
Degree: Doctor of Philosophy
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Description
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, MD
In 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 2010
Therapeutic 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 RELO
Salary for Manager is 113k with 10% bonus
And for Snr Biostat is about 90-100k, with 10% bonus
Job Responsibilities
10%
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 publications
10%
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 codes
5%
Review CRF
5%
Review and approve database structure and edit-check specifications
5%
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 FSR
5%
FDA contracts and regulatory meetings
? Draft response to questions from regulatory agencies
? Participate in preparing FDA briefing packages
? Attend meetings with Regulatory Agencies
Knowledge, Skills, and Competencies
Knowledge
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 information; maintains and adjusts to audience; ensures understanding; comprehends communication from others; provides clear and effective training to internal and external groups.
Continuous learning Makes specific efforts to improve and expand technical knowledge and skills; identifies new areas for learning; regularly creates and takes advantage of learning opportunities; uses newly gained knowledge and skills on the job; takes initiative to discover information about industry regulations and standards.
Strong decision making and judgment Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions and uses effective approaches for choosing a course of action or developing appropriate solutions; exercises appropriate judgment and involves others to obtain information; considers potential risks and makes the most appropriate decisions; communicates with all appropriate parties and ensures understanding of the resulting decisions.
Driving for results with quality Consistently produces quality results; completes tasks and projects requiring a great attention to detail; appropriately balances the need to meet deadlines with the requirement for quality products that produce strategic value; establishes stretch goals for self and others; works tenaciously toward achieving desired results.
Global vision Thinks globally in terms of commercialization; knows global regulations and protocols; demonstrates cultural sensitivity and works well with people globally; understands what we do as a company even though may not know the details and how they fit in.
Managing through influence Motivates and manages the performance of colleagues over whom he/she does not have direct authority; works with and appropriately influences many kinds of team and project members; pushes tasks and decisions down; invites input from others; provides appropriate feedback; steps up to conflicts and handles in an appropriate manner; can find common ground and get cooperation with minimum noise.
Strong planning and organizational skills Prioritizes projects and effectively manages resources; effectively coordinates schedules and allocates time to complete work; identifies more critical and less critical activities and tasks and adjusts priorities when appropriate; uses time appropriately to ensure work is completed effectively and efficiently.
Problem solving Consistently solves difficult problems with effective solutions; anticipates and identifies core problems, can see underlying or hidden problems and patterns and look beyond the obvious to solve problems effectively; asks good questions and probes for answers; applies insightful analysis; confronts tough or difficult issues.
Ability to be an effective team leader and/or team member Comfortable sharing information and working in teams; uses appropriate methods and a flexible style to help build a cohesive team and facilitate the completion of team goals; involves and informs others; models commitment to team expectations and responsibilities; finds ways to help the team accomplish goals.
Physical Demands and Work Environment
See attached.
Education and Related Experience
PhD in Statistics or Biostatistics with a minimum of 4 years of experience in the pharmaceutical industry, or MS in Statistics/Biostatistics with at least 7 years of experience.
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