at Terumo BCT
Posted on May. 18, 2017
JOB TITLE: BIOSTATISTICS MANAGER
Manages all aspects of biostatistics for Scientific and Clinical and provide consulting for Engineering projects. Provides input on study design, analyses, and statistical reports to Science and Clinical groups and manages statistical aspects of projects. May manage statistical programmers and/or Data Management personnel. Works on complex statistical problems in which analyses of data requires an in-depth evaluation of complex scientific, regulator, and business factors. Participates in meetings with Regulatory Agencies.
- Oversees execution of statistical analyses, preparation of the statistical methods and results sections for clinical investigation reports, and production of overall summaries (e.g., annual reports, Clinical Evaluation Reports)
- Collaborates in development of Data Monitoring Committee Charters and manages the providing of data and data analyses as outlined in the charter
- Develops systematic documentation of methods, results and statistical programming. Statistical programming may include creation of analysis specified in statistical analysis plan and ad-hoc analysis as requested.
- Assists in the design and testing of clinical databases and will consult with product development teams providing statistical expertise on new design features
- Participates in meetings with regulatory authorities and external advisors to coordinate the transfer of and review of data (CROs, central laboratories)
- Develops SOPs, dept procedure documents as required for functions within the role, ensuring consistency in statistical methodology, programming standards, and data specifications with all studies
- Collaborates with Science, Engineering to develop statistically based verification and validation acceptance criteria and analyzing field data to provide insight into trends, and Regulatory in defining strategic approach and with Clinical in producing Clinical Investigation Plans and Case Report Forms
- Provides statistical methodology for study protocols including sample size estimation, power calculation, and study design/conduct
- Plans all aspects of data analysis. Prepare and maintain the Statistical Analysis Plan (SAP) which includes the description of the planned data analyses, statistical methodology, derivation of analysis variables, and formatting of tables/listings/figures.
- Coordinate and ensure quality-controlled production of all tables, listings, and graphs for the clinical documents (study reports, publications, regulatory submissions, etc) and work closely with programmers to provide specifications for report tables and listings
- Reviews edit checks and Data Management Plans
- Provides Randomization schema for treatment assignment
- Evaluates statistical analyses software, determine use and manage implementation/execution
MINIMUM QUALIFICATION REQUIREMENTS
Master's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- PhD preferred in biostatistics/statistics or a related discipline
Minimum 5 years experience within the medical device, pharmaceutical, or biotechnology industry
- Global experience desired
- Direct experience with submission and regulatory interaction is desired
- Experience with direct management of personnel preferred
- A thorough knowledge of experimental design, time to event methods, general linear model, categorical data analysis and statistical computing required
- In depth knowledge of regulatory regulations and guidelines in medical device and/or pharmaceutical registration required.
- Knowledge and skill of SAS and PC application software such as sample size determination required
- Demonstrated effective cross-functional team skills, self-direction, and ability to work independently
- Must have a positive and proactive approach to identification and definition of problems, leading to proactive development and implementation of solutions
- Must demonstrate a relentless pursuit for solutions in a constructive manner while motivating others to do the same
- Requires a high level of adaptability and initiative as well as willingness to take ownership and accept responsibility for actions and decisions of the team
- Must have excellent organizational, technical, and verbal communication skills
- Demonstrate interpersonal skills and the ability to represent the business area with both internal and external contact
- Demonstrate and interact with diplomacy and tact while maintaining appropriate assertiveness and persistence
An equivalent competency level acquired through a variation of these qualifications may be considered.
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers .
Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Hong Kong and Tokyo.
Our company has almost $1B in annual revenues and has been voted and recognized as:
- Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
- Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
- One of Colorado's Healthiest Employers by Denver Business Journal (2014 & 2015)
- Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015
Our award-winning culture embraces:
- Leading technology through innovation and R&D
- Wellness programs
- Commitment to quality
- An environment that values, respects and rewards your individual contributions
- A philosophy of intentional growth and responsiveness to world health issues
Click Here to see what our associates have to say about our culture.
Each associate has a positive impact on our future by:
- Connecting to the lives of the patients we ultimately serve
- Growing through professional and leadership development activities
- Sharing company success through incentive plans
If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.