Senior Manager, Biometrics

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POST DATE 8/9/2016
END DATE 10/11/2016

US WorldMeds Louisville, KY

Company
US WorldMeds
Job Classification
Full Time
Company Ref #
217076
AJE Ref #
575822104
Location
Louisville, KY
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Masters Degree

JOB DESCRIPTION

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Overview

At US WorldMeds, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet medical needs.

US WorldMeds' commitment to patients is reflected in all that we do. We are a company driven by the knowledge that our work is important; we have the desire to make a difference. We offer our employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.

Job Skills / Requirements

The Senior Manager, Biometrics is responsible for leading biostatistics, statistical reporting deliverables and data management activities in support of all clinical development programs. This position plays a key role in providing strategic and operational statistical expertise to USWM clinical protocols specifically phase III development programs.

General Responsibilities:
- Provide strategic expertise for early through late stage clinical development programs
- Participate in vendor evaluation/selection and provide vendor oversight (programming / data management)
- Write / review statistical sections of reports and clinical protocols
- Instruct and provide statistical guidance to statistical programmers
- Oversee development of electronic data capture system for each study
- Provide operational oversight of data management activities
- Oversee Risk Based Monitoring (RBM) programming
- Serve as key driver of RBM initiative for USWM
- Review IWRS requirements and implementation when required
- Oversee the integration of clinical studies for regulatory submissions
- Write / review statistical analysis plans for clinical study reports and integrated summary documents
- Active member of protocol development core team providing input in design, outcome measures, endpoint assessments and sample size / power calculations
- Provide input on regulatory strategy for USWM programs

Minimum Qualifications:
- Master's Degree in Statistics with at least 10+ years of experience or equivalent related experience consisting of 15+ years of biometric operation experience
- In-depth working knowledge of SAS
- Strong leadership, cross-functional collaboration, communication and presentation skills
- Experience in interactions with regulatory authorities, with direct experience at advisory committee meetings a plus.
- Experience preparing biometrics activities for clinical trials phases I-III.

Additional Information / Benefits

US WorldMeds offers a competitive benefits package, including Medical, Prescription, Dental and Vision coverage, 401(k), Life and AD&D, Short and Long Term Disability, Long Term Care, and paid time off.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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This job reports to the Associate Director, Biometrics

This is a Full-Time position 1st Shift.