At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility.
We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right. We are a global Group, with over 9,900 employees and in 2020, our Group generated revenues of over $1.894 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.
At ConvaTec we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us as a Biostatistician and you’ll do the same.
About the role:
This position is responsible for performing activities related to the biostatistics function in support of ConvaTec clinical trials while maintaining a high level of quality and integrity of data analysis. Expertise will also be provided for support of publication activities (manuscripts, abstracts, posters), metrics, and participating in project teams.
We are open to candidates located in the UK or in the greater Lexington, Massachusetts area
Duties and Responsibilities :
- Key point of contact for the study team on all clinical trial biostatistics activities.
- Contribute to pre-clinical & clinical research protocols (including Post Market Studies) as a statistical expert in the areas of study design and sample size calculations.
- Provide expert review of investigator initiated studies
- Write and/or review Statistical Considerations sections for clinical research protocols.
- Write study specific Statistical Analysis Plans (SAPs) including the definition of data sets and the design of templates for statistical tables, figures, data listings and/or graphs for clinical summary reports.
- Perform statistical analyses and interpret results of these analyses. Prepare statistical summary reports.
- Ensure that analysis and programming work is documented and archived in a complete audit trail.
- Create and maintain biostatistics files for each assigned project and ensure inclusion of required documents in the Trial Master File.
- Work directly with study/project teams to identify statistical issues and propose and implement solutions.
- Provide statistical input to study reports, regulatory documents, publications, and other internal or external data requests. Perform statistical modeling and analyses as needed.
- Research and apply new statistical approaches as needed. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.
- Perform other related duties as assigned.
Skills & Experience:
- Master’s Degree in Biostatistics/Statistics with a minimum of 3 years of pre-clinical/clinical research experience (industry or academic setting) OR PhD with minimum of 1 year experience in pre-clinical/clinical research experience (industry or academic setting)
- Experience with study designs, power/sample size calculation, data analysis and simulations
- Proficiency in statistical software programming (i.e. SAS) with ability to product ad hoc tables
- Works both as a team member and independently engages and supports other members of the team and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.
- Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.
- Can establish strong working relationships with clinical and research and development teams.
- Has demonstrated principled leadership and sound business ethics: shows consistency among principles, values and behaviors.
- Seeks and welcomes feedback, responds to coaching, takes action to change.
- Effective use of oral and written communication skills to influence, inform or guide others.
- An understanding of clinical research, including the protocol/project relationship and key milestones
- A proven ability to deliver results according to timelines. Anticipates problems and creates solutions to minimize potential delay.
- Solid understanding of project planning and project management methods and the ability to apply them.
- Knowledge of team building strategies, communication and interpersonal skills.
Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.
This is a challenge more worthwhile.
This is work that’ll move you.
ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives: ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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