Senior Director, Biostatistics

PTC Therapeutics, Inc.•Warren Township, NJ

3d•$238,700 - $280,800•Hybrid

About The Position

The Senior Director, Biostatistics provides technical leadership and operational oversight for the design and implementation of clinical development programs and the associated clinical trials for the assigned therapeutic areas. This includes, but is not limited to: identifying optimal study designs, defining data analysis strategies, authoring and implementing statistical analysis plans, interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders. The incumbent may interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials. The incumbent works cross-functionally with internal departments and external resources on Biostatistics related issues. The Senior Director, Biostatistics ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Advanced degree in Statistics or a related statistical discipline and a minimum of 12 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO).
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
Ability to influence without direct authority.
Excellent verbal and written communication and 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.

Nice To Haves

Thorough/detailed understanding of regulatory requirements and guidance documents

Responsibilities

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, regulatory, and commercial teams. 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.
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.
Provide support on statistical deliverable for NDAs/BLAs and other submissions
Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as needed.
Performs other tasks and assignments as needed and specified by management.