Job Description

Location: MA or CT-based (with a Cadillac relocation package) and Hybrid office/home-working options available.

Our client is a financially stable rare disease company with over 2500 employees and an extensive pipeline of over 20 NMES and line extensions in development. They are now expanding and looking for a Senior Manager of Biostatistics to be responsible for the statistical activities in support of their clinical trials.

• The team is established but continues to grow and the role reports to an experienced Head of Biostatistics who likes to mentor, challenge, and support his team members.
• As the Senior Manager of Biostatistics, you will be a key member across several cross-functional development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and the preparation of regulatory submissions.
• On the offer is a high-end package with both bonus and LTI’s and there is full relocation package available if needed. 

Responsibilities include:

• Writing, authoring and/or reviewing protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents with minimum supervision.
• Performing and/or validating statistical analyses, advising on ways to maximize clarity of data display.
• Communicating results to cross-functional teams and providing data interpretation in study documents such as clinical study reports, and publications.
• Writing the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Contributing to or preparing statistical analysis plans and Data Presentation Plans.
• Collaborating with Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on the design of eCRFs.
• Providing statistical guidance on the conduct of ongoing trials.

Requirements:

• You will have a PhD in Biostatistics, Statistics, or equivalent and have a minimum of 4 years of pharmaceutical experience OR you will have an MS in Biostatistics, Statistics, or equivalent with at least 6 years of pharmaceutical experience.
• You will need to have excellent written and oral communication skills with excellent presentation and interpersonal skills.
• You will need to be flexible and well-organized and possess the ability to work well under pressure.
• You will also need experience in programming with SAS and experience with simulations (design, implementation, and interpretation).

If you are interested in hearing more about this role, or other similar opportunities in Biostatistics then, please send me a message or a copy of your resume to my personal email: Christian@AdvTalent.com or call me or my senior colleague Matt Greig at 908.332.9157 - we look forward to speaking to you!