Senior Lead Biostatistician Job in Phillidelphia 19102, Pennsylvania Us

Job Title: Senior Lead Biostatistician

Position Description

Capably applies knowledge of clinical trials design and analysis and statistics to provide study teams with comprehensive biostatistical support for both independent studies and integrated summaries of safety and efficacy.
Provide biostatistical consulting and support to sponsors to develop clinical trials.
Serves as technical lead on projects, interacts with sponsors on statistical issues, provides guidance to other employees on technical issues, reviews draft statistical plans and reports.

Position Responsibilities

Serves as primary client biostatistics contact for assigned projects
Serves as independent technical lead on projects.
Provides biostatistical consulting and support for statistical issues with regulatory authorities.
Develops comprehensive statistical analysis plans for both independent projects and integrated summaries of safety and efficacy for regulatory submissions.
Provides statistical analysis where standard methods are not appropriate.
Performs QA of TLGs
Reviews draft statistical analysis plans and provides comments.
Reviews and writes statistical method sections of protocols and estimations independently.
All other projects as assigned.
Serve as a mentor to junior level biostatisticians to help develop skills in the Global Biostatistics department.
Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
Keep detailed records of time spent on each project to allow accurate billing.
Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with.
Perform other work-related duties as assigned.

Position Requirements

PhD, or equivalent in statistics or closely related field
10-15 years direct experience in clinical trials design and analysis.
Fluent English communication skills (written and oral)
Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
Detail oriented, well organized.
Ability to work on several projects simultaneously.
Demonstrated knowledge of design of clinical trials and regulatory requirements.
Demonstrated experience with interacting with regulatory agencies (e.g. FDA, MHRA, EMEA, EU member states).

Benefits

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