Director, Biostatistics - Warren - PTC Therapeutics

Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material

Develops solutions to statistical and data analysis issues for clinical and regulatory. Communicates solutions cross-functionally.

Participates in vendor evaluation, selection, and management.

Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.

Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data in a way that supports a high-quality database for the planned analyses.

Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions.

Authors and reviews statistical and outcome sections of study reports and submissions.

Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities.

Performs other tasks and assignments as needed and specified by management.

A Master's degree in Statistics or a related statistical discipline and a minimum of 8+ years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.

Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies.

Demonstrated understanding and working knowledge of advanced statistical theory and its application in the pharmaceutical/biotechnology industry.

Prior BLA, NDA and/or MAA experience is highly desirable

Hands-on statistical programming skills using SAS and/or R.

Ability to influence without direct authority.

Proficient in Microsoft Office.

Excellent verbal and written communication skills.

Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Excellent understanding of regulatory requirements and guidance documents

5- 15%