Job Description
HM's Top 3:
- Experience as lead biostatistician in clinical studies (device preferred, but will consider pharma).
- Experience in adaptive study design, analyzing time-series data
- Experience in regulatory strategy development/input
Education Required: MS/PhD level in Biostatistics or Statistics Years’ Experience Required: 7+ with MS, 5+ with PhD Responsibilities may include the following and other duties may be assigned. Designs plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety efficacy and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In developmentphase projects prepares the statistical component of protocols which meet project objectives health authority guidelines and clinical trial methodology standards. Develops and/or applies statistical theories methods and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies outcomes and methods used. Provides specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct and the collection management and/or reporting of data.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS
Autonomy: Recognized expert managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager . Coaches reviews and delegates work to lower level specialists.
Organizational Impact: Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity: Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation . Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience
Job Tags
Remote job, Contract work, Immediate start,