Sr Biostatistician II

Work Schedule

Environmental Conditions

Job Description

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 analysisreport preparation and advising other project 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 departments 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 regulatoryagencies 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.

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

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 reporting
of 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 timelinesconduct 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

Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast simple repeated movementsof the fingers hands and wrists.
Frequent mobility required.
Occasional crouching stooping bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptopcomputer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen toand understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work
schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions
with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance