POSTITION

Clinical Biostatistics Project Manager

SUMMARY:
This position is responsible for providing biostatistical support including application of statistical and research methodological principles for the design, execution and analysis of clinical trials, and for ensuring the data activities are conducted in accordance with regulatory and company standards. Interfaces with data management, field clinical monitors, clinical project managers, senior Clinical Sciences management, medical directors, and functional management. Works under the direction of management on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

RESPONSIBILITIES:
? Takes an active role in defining the strategy for clinical trials including recommendation of appropriate research design, definition of patient population, measurement of outcome variables, and hypothesis development
? Author and provide input on relevant sections of clinical research protocols including endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).
? Liaison with health outcomes/reimbursement group as required.
? Review CRFs to ensure consistency with Protocol and adequacy in collecting data to meet objectives defined in the Protocol.
? Define programming requirements of trial and ensure timely completion.
? Manage the efforts of other Biostatistics staff, as appropriate.
? Author or manage the development of Statistical Analysis plans (SAPs) for assigned projects.
? Generate tables and listings, conduct statistical analyses, and interpret clinical trial data according to the analysis plan.
? Interface with outside biostatisticians when external expertise is required.
? Manage CRO biostatistics activities.
? May be accountable for one or more concurrent clinical studies.
? May train, and mentor biostatistics staff on processes.
? Participates in and assists in the development and approval of global biostatistics strategies in collaboration with Clinical Sciences management.
? Attends investigator and coordinator meetings, representing the biostatistics group.
? Manages biostatistics release and review meetings for clinical projects; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for projects.
? Participates in the dissemination of clinical information to the biostatistics team members and extended core team members, as appropriate.
? Provides clinical support in working with Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel.
? Assists in developing and maintaining biostatistics infrastructure such as the drafting and/or reviewing of SOPs, DOPs, and Work Instructions.

REQUIREMENTS:
Masters-level degree required in biostatistics, statistics, or public health. Ph.D. degree preferred. 5-7 years experience in biostatistics and medical devices/pharmaceutical clinical trials, and 1-3 years managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports.

WORKING CONDITIONS:
General office environment, approximately 10%-30% travel to research laboratory or hospital settings, meetings and other facilities. Potential exposure to blood borne pathogens and other potentially infectious materials

COMPETENCY EXPECTATIONS:
Ability to understand strategic goals and match the business needs of the company. Ability to develop good interpersonal relationships with medical professionals. Good verbal and written communication and presentation skills. Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies. Ability to independently manage and provide significant tactical and leadership guidance to clinical team. Independently motivated. Demonstrated ability to manage multiple projects, complex projects and international projects.

LOCALE

Good for applicant living in Framingham, Boston, Marlborough, Worcester, Waltham, Newton, Maynard, Hudson, Milford, Franklin, Lexington, Needham, Dedham, and surrounding areas.

HOW TO APPLY

Reply to: agilman[at]primassist.com with a word document resume