Sr Biostatistician II

Job Description :

Work Schedule

Environmental Conditions

Summarized Purpose:
Serves as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complexprotocols, projects, or NDA projects, including coordinating with other divisions and interacting with theclient and regulatory agencies. Mentors others in the application of more complex statisticalmethodologies. Performs project management functions relating to the administrative and scientific
activities of team members across multiple complex projects. Provides senior-level oversight of statisticalaspects 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 tosimple to complex study proposals and bids and representing the department at bid defenses. Organizes
teams and implements strategies to ensure process and programming efficiencies on complex studies.

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 withthe 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 towriting 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 resourcingrequirements.
. 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 ofspecialization resolves a wide range of issues in creative ways. This job is the fullyqualified, career-oriented, journey-level position

Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to6+ years). Master's degree in statistics, biostatistics, mathematics or related field preferred.

Knowledge, Skills and Abilities:
. Comprehensive SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH)
. Capable of directing and promoting teamwork in a multi-disciplinary team setting
. Capable of reviewing current processes and identify potential process improvements
. Comprehensive understanding of a wide variety of clinical trials/designs and corresponding reportingof data
. In-depth understanding of interpreting the results from statistical analyses of complex data
. Strong project management skills, as shown through management of multiple projects
. Demonstrated initiative and motivation
. Excellent written and verbal communications skills, including proficiency in the English language
. Substantial organizational, time management, and planning skills to create and follow timelines,conduct long-range planning, adapt to changing priorities and handle multiple projects
. Strong interpersonal skills and positive attitude to work effectively in a team environment and act asa liaison with other department

Management Role:
No management responsibility