Senior Biostatistician II

3 weeks ago

Atlanta, United States Mindlance Full time

Job Title: Senior Biostatistician II
Job Location: REMOTE


MUST HAVES/ Top Skills:

· Lead level experience to react to FDA questions.

· Experience on ADaM Datasets and produce and review TLF shells.

· Submission experience.

· Preferred: submission response experience – rapid response.

SUMMARIZED PURPOSE:

· Serves as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complex

· protocols, projects, or NDA projects, including coordinating with other divisions and interacting with the client and regulatory agencies. Mentors others in the application of more complex statistical

· methodologies. Performs project management functions relating to the administrative and scientific

· activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.

· Represents the department to clients on simple to complex study design matters, directly contributing to simple to complex study proposals and bids and representing the department at bid defences.

· Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.

ESSENTIAL FUNCTIONS AND OTHER JOB INFORMATION:

Essential Functions

· Ensures compliance with the activities outlined in the department's SOPs and contribute changes as needed. Follows departmental procedures for statistical analyses and programming work.

· Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across challenging projects; provides senior review on projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.

· Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related documentation.

· Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. Reviews statistical analysis for key efficacy endpoints.

· Reviews specifications for analysis database, oversees its development, and assures completeness for use in all programming. Oversees collaboration with programmers and data management personnel as to database maintenance, updating, and documentation. Supervises creation of table and listing specifications.

· Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.

· Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.

· Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.

· Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, contributing to performance planning, and providing resource planning.

· Provides input on hiring recommendations, department policies, and resourcing requirements.

· Acts as representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.

· Job Complexity Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

· Job Knowledge A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

Supervision

· Received Normally receives little instruction on day-to-day work, general instructions on new

· assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Business Relationships

· Represents the department as a prime contact on projects. Interacts with internal

· and external personnel on significant matters often requiring coordination between

· functional areas. Networks with senior internal and external personnel in own area

· of expertise.

EDUCATION AND EXPERIENCE:

· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’).

· Master's degree in statistics, biostatistics, mathematics or related field

· In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the

· requirements of the role.



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