Posted in Other 30+ days ago.
Type: Full Time
MANAGER BIOSTATISTICS
Job Locations US-IL-Deerfield
Req No.
2020-12062
Type
Regular Full-Time
Client
Advanced Clinical
OVERVIEW
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there s no better place to grow your career than Advanced Clinical.
A Manager, Biostatistics is responsible for overseeing biostatistics activities for Advanced Clinical and for ensuring the quality of deliverables.
RESPONSIBILITIES
Managerial Responsibilities
* Train, mentor, monitor, and supervise Biostatisticians
* Coordinate activities and assignment of resources for assigned projects and ensure that projects stay on target
* Ensure overall quality of biostatistics deliverables
* Conduct performance evaluations for direct reports, including guidance toward reaching organizational and career goals
* Inform management of projects status, statistical issues and employee issues
* Assist in monthly revenue reporting for assigned projects
* Understand the Advanced Clinical (AC) overall financial plan and our contribution to and support of AC s overall financial goals
* Maximize productivity of direct reports to meet/exceed AC budget goals
* Write training and establish training programs for new processes
* Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop processes
* Other management responsibilities as requested by the Senior Director of Biostatistics
Standard Operating Procedures (SOPs)
* Be familiar with and follow department SOPs
* Ensure staff is adequately trained on and following SOPs
* Create, revise and review SOPs to recognize and prevent potential regulatory issues
Business Development
* Assist with RFP/RFI completion
* Attend sales meetings as requested by Business Development
Statistical Responsibilities
* Apply knowledge of statistics and drug development to fulfill primary duties
* Implement and support CDISC, ICH, and other regulatory standards
* Review protocols, CRFs, and database structures
* Prepare, review, and approve statistical analysis plans to ensure that appropriate statistical analyses are proposed and implemented
* Provide statistical support for Independent Data Monitoring Committees and interim analyses
* Ensure the accuracy, quality, and appropriateness of the statistical tables, listings, graphs, and derived datasets for Clinical Study Reports and for other regulatory filings, including IND annual reports and Integrated Summaries of Safety and Efficacy
* Effectively communicate statistical concepts and arguments to colleagues, clients, and regulatory agencies
Additional Responsibilities
* Participates in the management team responsibilities as assigned by management.
QUALIFICATIONS
Education: PhD or Master s degree in Statistics or a closely related field
Experience: A minimum of 6 years of experience in pharmaceutical development and SAS programming for statistical analysis. Candidate must be familiar with regulatory requirements. Excellent oral and written communication, project management, and organizational skills are required.
Training: The below list includes the general training subject, and not necessarily the exact name of the training course obtained.
* Applicable Standard Operating Procedures
* Good Clinical Practices (21 CFR; Guidance Documents including ICH Guidelines)
* Drug Development and Approval Process
What s in it for you* Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:
Our Culture: https://careers.advancedgroup.com/embrace-our-culture
Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group s career site here.
It is Advanced Group s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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