Senior Manager Biostatistician Consultant (remote in UK- Outside IR35) 24 months contract
Posted Today by ClinChoice
Negotiable
Outside
Remote
United Kingdom
Summary: ClinChoice is seeking a Senior Manager Biostatistician Consultant to work directly with a client while benefiting from the support of a global CRO. The role involves contributing to the design of clinical trial protocols, drafting statistical analysis plans, and performing statistical analyses for regulatory submissions. Candidates should possess strong leadership skills and the ability to work independently in a client-facing environment. The position requires a solid background in statistics or biostatistics, with significant clinical trial experience.
Key Responsibilities:
- Collaborate with study team members and project statisticians to design early/late-stage protocols across multiple therapeutic areas.
- Draft protocols or amendments and develop statistical analysis plans.
- Perform statistical analyses for interim and final reports for regulatory agencies.
- Support submission activities, including design, analysis, and reporting of integrated summaries for safety and efficacy.
- Attend study team meetings and contribute statistically.
- Organize and schedule study deliverables in collaboration with Statistical Programmers and Data Managers.
Key Skills:
- MS or PhD in Statistics or Biostatistics.
- PhD +4 years or MS +9 years of clinical trial experience in biotechnology or pharmaceutical companies.
- Hands-on experience with Phase I/II/III clinical trials and proficiency in SAS programming.
- Desirable excellence in R programming.
- Excellent oral and written communication skills.
- Previous experience with regulatory submissions in the US, Europe, Japan, and Rest of the World is desirable.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: Senior
Industry: Other
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for an Senior Manager Biostatistician Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Job Duties
This position is responsible for working with study team members and the project statistician to contribute to design of early/late-stage protocols across multiple therapeutic areas, help draft protocols or amendments, develop and write statistical analysis plans, and perform statistical analyses for interim and final reports to be submitted to regulatory agencies. The position will also support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy. Attendance and statistical contributions at study team meetings are expected. Within the BDM Department, leadership skills are needed to contribute to the organization and scheduling of study deliverables in collaboration with Statistical Programmers and Data Managers.
Qualification And Required Skills
MS or PhD in Statistics or Biostatistics PhD +4 years (or MS +9 years) clinical trial experience in either a biotechnology or pharmaceutical company Hands-on Phase I/II/III clinical trial experience and proficient in SAS programming. Excellence in R programming desirable. Excellent oral and written communication skills. Although not required, previous experience with regulatory submissions in the US, Europe, Japan, and Rest of the World, is desirable.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.