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Job Description
KEY RESPONSIBILITIES:
This role entails a wide variety of responsibilities and client exposure; we encourage our technical Statisticians to think outside of the box and to be the go to person for the field in which they are an expert, both internally and as a point of contact for clients.
Below is a summary of the types of tasks you could be carrying out on a daily basis. As with many roles at Veramed, you have the opportunity to shape their direction dependent on client needs and your own career aspirations.
STATISTICS & PROGRAMMING
- Provide statistical consultancy to clients and colleagues, understanding research questions, identifying appropriate methodology, and advising on implementation.
- Develop and deploy novel and computationally challenging statistical analyses for ongoing studies in collaboration with project lead statisticians and programmers.
- Develop expertise within the company; equipping others to identify, understand and implement advanced statistical methods through training, mentoring and contributions to knowledge bases & code repositories.
- Understand the regulatory requirements related to design and analysis of studies.
- Participate in protocol summary development. Give input into study design, efficacy and safety parameters and planned statistical analyses. Perform sample size calculations and study design simulations.
- Participate in protocol development, review and approval.
- Author/review Statistical Analysis Plans (SAPs).
- Perform exploratory analyses.
- Review clinical study reports and provide input on interpretation of results.
- Review and input into regulatory documents and interactions.
- Act as the lead statistician on behalf of the client for one or more clinical studies within a clinical program or across multiple clinical programs.
- Author, contribute to, oversee and review abstracts posters, presentations, and manuscripts for publication. Ensure accuracy of all biostatistical aspects of such documents.
- Support and mentor more junior statisticians on the team.
DAILY INTERACTIONS:
- Act as the go to Subject Matter Expert (SME) in the business for your particular field providing technical insight, consultancy and strategic direction internally and externally.
- Work with study teams to implement challenging analyses.
- Communicate rationale and mechanics of study designs, analysis methods and the results of clinical trials.
- Lead study teams effectively.
- Present study updates internally and at client meetings.
- Share scientific, technical and practical knowledge within the client study team and with internal colleagues.
OPPORTUNITIES FOR:
- Presenting at conferences and authoring papers.
- Developing and executing innovative statistical methodologies, study design and/or efficiency optimisation ideas.
- Line management and peer mentoring.
- Contributing to business process improvements and authoring/presenting internal training.
- Contributing to initiatives that consider employees, the environment and our local communities as part of our B Corp accreditation.
WHAT TO EXPECT:
- A warm, friendly working environment in which to thrive both personally and professionally.
- A supportive, open-door management policy that will aid in your development and provide you with the tools to take your career to the next level.
- Exposure to a wide range of clients and projects, allowing you to diversify your workload and work closely with some of the biggest pharma companies in the industry.
- Work with a truly unique CRO that’s doing something different when it comes to managing staff, projects and building relationships in the industry.
- The ability to truly own your role and develop your skills and experience.
ADDITIONAL REQUIREMENTS:
- Appreciation of the theoretical underpinnings of relevant statistical methodologies and the consequent considerations in implementation.
- Experience implementing statistical analyses in software that does not support it “out of the box”.
- Understanding of clinical drug development process, relevant disease areas, estimands and different study designs.
- A good communicator and influencer at all levels of the organisation, with the ability to impart knowledge clearly on a particular subject area(s).
- Awareness of industry and project standards & ICH guidelines.
- Interpersonal/teamwork and communications skills for effective interactions.
- Proficiency in data handling using SAS or other statistical software (e.g. R).
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
- Demonstrated problem solving ability and attention to detail.
- Ability to work independently and as part of a team.
If this role sounds right for you, please click 'apply now' to submit your application. We'd love to hear from you!
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.
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