As a Principal Biostatistician you are a key member of the Biostatistics Team. The Principal Biostatistician will serve as a primary statistical representative for biometrics standalone projects or otherwise complex studies. Will effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. Development and review of statistical analysis plans based on study specific documents and sound statistical methodology. Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures. Have senior oversight to junior level biostatistics staff. Provide statistical consultation for clinical programs, acting as subject matter expert within the Biostatistics department. Key member in implementation of departmental objectives and strategies.

Position Responsibilities:

·         Lead high complexity studies in various phases of development.  Provide senior oversight on low or moderate complexity studies.

·         Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple projects simultaneously.

·         Collaborate with internal and external project team personnel (e.g., Sponsor company, external vendors, and within Catalyst Clinical Research) as needed to meet project deliverables and timelines for statistical data analysis and reporting.

·         Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management.

·         Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies.

·         Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, and/or bid defense meetings.

·         Provides statistical advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, and document review/approval.

·         Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology.

·         Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures.

·         Ensure the quality and integrity of data analysis and reporting by programming checks using SAS.

·         Monitor project budgets as it relates to the scope of work and support project forecasting efforts.  Meet with members of Finance to assess project budgets and report study status.

·        Provide statistical consultation for clinical programs and act as subject matter expert within the Biostatistics department.  

·        Key member in implementation of departmental objectives and strategies, including but not limited to SOP development, training, professional development, standardizations, and team building activities. 

Position Qualifications:

Education:

·         Master’s degree, equivalent, or higher in biostatistics or a related field.

·         A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.

Experience:

·         A minimum of 7+ years of relevant work experience.

·         4 years DMC experience

·         Previous experience in pharmaceutical research or CRO setting required.

·         Prior experience in multiple therapeutic areas required, with experience in Oncology preferred.

Required Skills:

·         Knowledge of clinical trial study design and multiple therapeutic areas.

·         Able to work independently on multiple, concurrent projects.

·         Lead study team meetings as needed.

·         Capable of conducting exploratory statistical analyses using statistical software packages.

·         Proficient with Microsoft Office Suite.

·         Excellent written and oral communication skills.

·         Strong organizational, problem-solving, and analytical skills.

·         Ability to manage priorities and workflow.

·         Versatility, flexibility, and a willingness to work within constantly changing priorities.

·         Proven ability to handle multiple projects and meet deadlines.

·         Ability to deal effectively with a diversity of individuals at all organizational levels.

·         Commitment to excellence and high standards.

·         Creative, flexible, and innovative team player.

·         Good judgement with the ability to make timely and sound decisions.

·         Ability to travel for meetings or training activities.

·         Ability to program simple checks for ADaM or TLF review using SAS and/or R.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.