Job Description:

Manager, Biostatistical Operations

Job Location

US-NY-Rochester

Overview

BASIC PURPOSE

Manage and coordinate all statistical operations activities including resource planning and task assignment to ensure adherence to contract deadlines for sponsor deliverables, cross-functional communication regarding planned outputs and timelines, management of statistical department staff, and reporting of departmental productivity, quality, and revenue metrics.

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Coordinate activities of Statistics group as well as other department Management as applicable.


1. Hold regular meetings with statistical department staff to plan the most efficient resource allocation to meet contract deadlines.


2. Liaise with project management, medical writing, and cardiology consultants to ensure operational efficiency and on-time completion of sponsor deliverables


3. Propose revisions to existing or development of new workflows and procedures, and present to management for approval




1. Manage the Statistics group staff.




1. Assist the Director, Clinical Biostatistics, in strategic planning and resource allocation for the department


2. Manage staff in accordance with the organization’s policies and applicable regulations


3. Approve actions on human resource matters, appraise performance and guide professional development, address employee relations issues.


4. Accountable for the project level work of staff including awareness of timelines, scope and resourcing strategy.


5. Support the development of statistics training programs

1. Collaborate with the ERT Project Management, Data Management and other Operations teams to ensure appropriate and consistent data collection parameters.




1. Ensure the department is adequately represented at internal and external meetings where Statistics attendance is required.


2. As necessary, ensure that the post-processing data QC is completed prior to client deliveries and that poor data quality trends are communicated to the appropriate group.

1. Develop and track departmental productivity, quality, and revenue metrics.

1. Ensure adherence to global SOPs and WPGs.




1. Recommend and implement process improvements.


2. Keep all SOPs and WPGs up-to-date.


3. Author and implement study-specific SOPs.


4. Maintain excellent communication with management, clients and internal teams regarding department activities.


5. Oversee the maintenance of training logs for all trainees and new staff members.

OTHER DUTIES AND RESPONSIBILITIES:

1. Related projects and duties as assigned.

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.

Qualifications

QUALIFICATIONS AND SKILLS NEEDED:

Education:

• Master’s degree in Statistics or related field preferred. 

Experience:

• At least 5+ years of experience in statistical analysis for clinical trials and 3+ years of management experience preferred.


• Strong project management, organizational, and leadership skills


• Familiarity with ERT products and service lines preferred.


• Excellent verbal and written communication skills.


• Familiarity with the clinical trials environment.


• Highly customer service focused.


• Computer competencies to include Microsoft Outlook, Word, and Excel.


• A minimum of four years of internal company experience in Statistics or similar industry experience preferred.


• Ability to react quickly to an ever-changing environment with excellent problem solving skills.

ERT is a growing and rewarding place to advance your career, especially for those who are passionate about finding solutions that improve lives – or save lives – for millions of people around the world.  Our success starts with caring and collaborative people, from the recent college grad who’s just getting started to the seasoned professional with a wealth of knowledge, skills and experience.  Together, we’re making a difference.

 
ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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