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Job Description

Senior Principal Biostatistician

Region: Americas
Location: Woburn, MA

Posted Date: 09/14/2022

Who We Are

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer 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. We’re a fast growing; dynamic organization and we seek an experienced Sr Principal Biostatistician to help us with our growth.

What You’ll Do

As the Sr Principal Biostatistician, you will have responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval or marketing purposes. This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts.

  • Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
  • Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
  • In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
  • Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.
  • Develops statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports.
  • Provides specifications and directions to the clinicians/statistical programmers.
  • Supports the regulatory review and approval of the experimental therapies.
  • Partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
  • Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature.
  • Research and contribute to application of novel statistical theories, methods, and software.
  • Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
  • Identifies potential threats to study credibility, validity, data integrity and works with study team to prevent, track, and manage potential problems.
  • Writes the statistical analysis plan for the study, if required.
  • Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods. Methods must be appropriate for the kind of data collected and required assumptions must be tested.
  • Validates and provides clear documentation of analysis programs.
  • Writes Results and Methods sections of reports and manuscripts as needed, and ensures interpretation of statistical and clinical findings in regulatory submissions, reports, and manuscripts accurately reflect the data collected.
  • Consults with other (e.g., non-clinical) staff on statistical and analysis issues.
  • Contribute to development of policies and procedures for process improvements and standardization for the department and the statistics group.
  • Attends and contributes to project and department meetings.

Who You’ll Be

  • 10+ years of experience in biostatistics supporting development of medical devices and/or pharmaceutical. (Preferred Qualifications):
  • Master’s degree or PhD degree in Biostatistics, or Statistics and minimum 2 years of statistics experience within medical device industry or pharmaceutical industries
  • Statistical experience in clinical trial design and data analysis
  • Strong applied statistical skills, including survival analysis, regression modeling, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, missing data strategies and multiple testing strategies
  • Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package
  • Prior experience in FDA or global regulatory submissions.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR)
  • High level of knowledge of clinical trial methods and execution
  • High degree of expertise regarding research data management
  • High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel)
  • Demonstrated ability to communicate technical content to non-statisticians (written and verbal)

What to Expect from Sirtex

If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives.
  • A working culture of respect, diversity, and performance to help facilitate an inclusive culture.
  • Attractive compensation and benefit packages which are practical, robust, fair, and equitable.
  • A place to grow through career development and training opportunities.

Conditions of Employment

  • Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
  • Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
  • Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Apply Now!

Be part of an amazing team that is helping to save lives, every day!