Senior Manager/Director Biostatistics & Data Management (Seattle, WA)
Description
This position manages a staff of biostatistics and data management professionals engaged in planning the statistical and data management design of clinical trials. Participates in the preparation of IDEs, PMAs and other reports for management and government regulatory agencies for specific medical device programs. Actively hires, trains and supervises staff during the performance of clinical trials. May have up to 3 direct reports and work through intermediate managers. There is also responsibility for indirectly managing the performance of any outside contractors.
POSITION RESPONSIBILITIES / ESSENTIAL FUNCTIONS - Biostatistics: Directs the design, development, modification and evaluation of all clinical programs' biostatistics. Performs or supervises the monitoring of statistical analyses and develops tracking systems to determine the efficiency of clinical trials. Responsible for the statistical design of clinical trials. Research the clinical indication and develop trial size and design parameters. Participate in investigators' meetings. Prepare statistical analysis plans for clinical trials. Make informed decisions regarding appropriate analysis of clinical trial data based upon sound statistical knowledge.
- Regulatory: Provides statistical support to define the optimal strategy on regulatory submission activities related to clinical and preclinical development programs. Provides data and documents for regulatory submissions. Represents biostatistics during interaction with regulatory agencies.
- Data management: Directs or supervises the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review. Collaborates and coordinates with others to design and implement clinical protocols and data collection systems. Develops systems for organizing data to analyze, identify and report data and trends. Manages data management issues by review protocols for cross-project consistency, and identify and design, with Clinical Operations, standard Case Report Form (CRF) modules to meet objectives. Develops data quality plans. Provides early strategic input into protocol design focused on data management issues. Review and resolve data discrepancies for standardized data validation systems and procedures. Responsible for data management projects that have been contracted with CRO's.
- Management: Provides and implement recommendations to the Company to maintain and lead a Biostatistics and DM team. This position will develop and implement methodologies and standards for the management, analysis and presentation of data from clinical trials. Develop and manage Biostatistics and DM budget, contribute to evaluation and selection of Biostatistics and DM outsourcing and software procurement. Effectively appoint, manage and train all department staff by setting clearly defined goals, and regularly reviewing progress and taking action as appropriate.
- Perform other related duties as assigned or requested.
REQUIREMENTS
Bachelor’s degree in Biostatistics or equivalent. Advance degree required for Director level role; Masters or PhD level knowledge in Statistics or Biostatistics. 10+ years of Biostatistics/Data Management experience in medical device / biotech / pharmaceutical industry; at least 5 years experience in a management role. Outstanding communication skills (verbal and written). Excellent working knowledge of FDA/ICH regulations and guidelines. Excellent judgment, negotiation and problem solving skills. Must have advanced data processing and/or computer programming skills, and advanced knowledge of statistical techniques, terms, methodologies and applications software. Able to handle complex personnel issues; proven leader of people and projects. Excellent analytical skills; well-organized. Ability to effectively synthesize and communicate complex medical and scientific information to physicians and non-physicians. Entrepreneurial spirit with "make-it-happen" attitude. Committed to teamwork; track record of being a valued team player. Takes initiative to identify and meet needs, resolve issues and recommend appropriate actions. Reputation for business integrity and trustworthiness. Must be able to utilize Microsoft Office Suite, clinical data management systems, SAS, and statistical software tools.
If this position interests you and or you know someone who will qualify for the position, please reply to
Bonnie Zaddach
Consultant / Agent
Advantage Medical Recruiters
952-474-4160 (w)
952-314-1061 (f)
mailto: bzaddach [at] jobsamr.com
www.jobsamr.com
URL: www.datashaping.com/jobs16789e.shtml
Please mention datashaping.com when applying. Thank you.
|
