Manager Biostatistics

Location
Waltham, MA
Posted
Mar 12, 2018
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Company Overview

Eloxx Pharmaceuticals, Inc.  (http://www.eloxxpharma.com/ ) is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. These nonsense mutations have been identified in over 2,000 rare and ultra-rare diseases.  As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an investigational, novel translational read-through inducing drug designed to restore synthesis of full-length functional proteins. ELX-02 is an investigational agent undergoing clinical trials and has not been approved by any global regulatory body. Eloxx was founded in 2013 and is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.

This is an opportunity to join a growing and energetic team, build a high performing company, gain personal development and transform patient lives.

Job Summary

Performs the design, development, modification and evaluation of a technical infrastructure to expedite conducting and evaluation of clinical trials and basic research.  Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials.  Interacts with clinical investigators to determine hardware/software compatibility.  Maintains expertise in state-of-the art data manipulation and statistical analysis.

Essential Job Responsibilities

  • Ensures statistical integrity of clinical studies conducted in support of projects. 
  • Plans and conducts analyses of clinical studie4s for NDAs, study reports, advisory committee meetings, publications and presentations.
  • Provides strategic input into clinical development plans.
  • Reviews case report forms to ensure proper data collection.
  • Provides statistical advice to clinicians and other job functions.
  • Represents sponsor interactions with regulatory agencies.
  • Manages data collection and component of CROs pertaining to assigned clinical studies.
  • Creates randomization files.
  • Contributes to the advancement of research in clinical trials methodology.

Qualifications/Experience

  • Requires a BA in statistics with a Master's degree preferred
  • 8-10 years related experience in the biotech/pharmaceutical industry; or equivalent combination of education and experience
  • Ability to effectively communicate analysis and data to senior leadership
  • Ability to travel 25%.

Interested candidates can click "Apply now"