Clinical Research Biostatistician
Clinical Research Biostatistician
Sirtex Medical is a global healthcare business with offices in the US, Australia, Germany and Singapore, working to improve outcomes in people with cancer.
Our current lead product is a targeted radiation therapy for liver tumors called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries.
Our mission is to improve the quality and longevity of patient’s lives by providing interventional oncology solutions.
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.
- 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 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 firstname.lastname@example.org
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