ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses.

• 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.

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

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Advanced 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.

* Special knowledge or skills needed and/or licenses or certificates required.

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

• Demonstrated understanding and working knowledge of 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.

• 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.

*Special knowledge or skills and/or licenses or certificates preferred.

• Excellent understanding of regulatory requirements and guidance documents

* Travel requirements

• 5- 15%

*Physical requirements

• Office based position

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EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.