Location: Woburn, MA
Advertising Date: Thu 28 May 2020
The Principal 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.
This individual will maintain 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.
- 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 5 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;
- Proven experience writing SAPs.
- 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 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 email@example.com