Clinical Research Biostatistician

Region: Americas
Location: Woburn, MA

Advertising Date: Wed 22 August 2018

The Clinical Research Biostatistician is an individual who takes a key role in the development and implementation of the clinical/medical program and post-market planning and analysis for manuscripts and health economics.

The Clinical Research Biostatistician maintains the statistical integrity of clinical studies, evaluates the statistical plans for Investigator-sponsored studies, assists in the planning and analysis of manuscripts and provides support for global health economics.  

Responsibilities

  • Manages all biostatistics aspects of clinical studies sponsored or supported by the company:
  • Provide statistical expertise for design of clinical study protocols consistent with the company’s clinical development strategy;
  • Develops statistical analysis plans according to regulatory requirements and study objectives defined in the study plan;
  • Provides assessment of statistical strategy for all trials and defines key datapoints required to meet study endpoints;
  • Assesses data collection tools to ensure data collection will meet the objectives of the endpoints and statistical analysis plan;
  • Direct the programming of summary tables, data listings and graphical representations of clinical trials data, as needed, in collaboration with external vendors if applicable;
  • Provides expertise  for  defining  data  clarification  and  validation  processes  to ensure data validity and integrity;
  • Provide expertise for efficacy and safety analyses as needed;
  • Perform (directly or by overseeing external vendors’ activity) all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data;
  • Prepare key sections of clinical study reports and various regulatory documents;
  • Perform statistical QC of final clinical study reports;
  • Provide statistical support  to  answer questions from  external  clients  (such  as regulatory agencies, Investigators, payers…);
  • Contribute to the development of standard operating procedures for clinical trials;
  • Participate to strategic, regulatory, sponsor, investigator meetings, and any other multifunctional meetings, as needed;
  • Manages the SAS Clinical Development System;
  • Provide training and guidance on statistics and methodology to clinical research staff;
  • Ensures all clinical designs are developed in compliance with ICH-GCP ISO 14155, other applicable guidelines/regulations, and the company SOPs;
  • Undergo all formal Training Events as may be Directed from time-to-time;
  • Observe and Comply with all Sirtex Corporate Policies;
  • Work within and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
  • Work within and ensure adherence to Health, Safety and Environment Management Systms, instructions and other requirements.

 Educational Perquisites and Skill Requirements

  • Master’s degree in biostatistics, statistics or other related, scientific field and at least four years of relevant professional experience; or an equivalent combination of relevant education and/or experience;
  • A PhD in biostatistics is preferred;
  • At least 2 years experience in medical device in addition to any experience in pharmaceutical and bio-technology company or CRO required. Experience in oncology field is a plus;
  • Excellent analytical skills with the ability to process scientific and medical data;
  • Able to work independently;
  • Excellent knowledge of statistical programming;
  • Expertise in  manipulating  and  analyzing  data  (SAS and equivalent statistical software);
  • Ability to identify data issues, present problems, and implement solutions;
  • Capability of  communicating technical concepts clearly, concisely and understandably to non-statistical colleagues;
  • Good leadership, organizational and time management skills with the ability to multi-task;
  • Familiarity with device clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP, ISO 14155).        

Training Requirements

  • Training and certification in ISO 14155 and ICH-GCP guidelines as appropriate
  • Training in Sirtex Quality System procedures, work instructions and other Quality System requirements

HOW TO APPLY:

To apply, please click the apply button or email your cover letter and resume to Human Resources at recruitment@sirtex.com


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