Principal Biostatistician - FSP project, Remote

Proclinical are working with a well-established company committed to making a positive impact in the healthcare industry. Currently, our client is seeking an active candidate who can join the team of our client on a permanent basis to be a key member of its biostatistical team.

Key Responsibilities

• Contribute biostatistical input to the design of the program, protocol input such as the layout of the study, sample size calculations, patient randomization, and quantitative aspects of case report form design.
• Assess data management coding conventions, edit checks, and database structures for projects.
• Prepare clinical summary reports, such as statistical analysis plans, derived data, and figures, with a focus on data listings and tables.
• Statistical analysis, Interpretation of data and reporting of results.
• Prepare statistical methods sections for integrated study reports.
• Provide feedback on draft integrated study reports as they are being prepared.
• Respond to regulatory questions regarding the design of the program, as well as labeling claims following submission.

• Present at meetings with clients and investigators in order to help them understand the project.
• Provide biostatistical input to research proposals and participate in proposal defense meetings, as well as provide presentations at marketing meetings with prospective clients, as needed.
• Ensure that team members are coached and mentored on a regular basis.

Key Skills and Requirements

• Masters or Ph.D. degree in statistics, biostatistics, or related field with experience in pharmaceutical industry.
• It is essential that you have experience with oncology.
• A thorough understanding of the design and analysis of studies in a therapeutic area, as well as the applications of statistical analysis.
• An excellent understanding of a wide range of principles, theories, and concepts in statistics and experimental design; should be capable of applying these to the development and analysis of clinical trials.
• It is essential to have a solid understanding of clinical trial methodology, regulatory requirements, statistics, and statistical software packages, including SAS.
• An understanding of the regulatory submission process.
• It is essential that you are capable of translating clients' needs into statistics practice and educate clients on how statistics can be used in their everyday lives.
• Strong interpersonal and project management skills, as well as excellent verbal and written communication skills

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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