Senior Director, Biostatistics

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

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.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/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.

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 12 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO).

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 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.

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

• Thorough/detailed understanding of regulatory requirements and guidance documents

Travel requirements

• 5- 15%

Expected Base Salary Range: $238,700 - $280,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

#Li-NM1

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.

Click here to return to the careers page

Welcome to PTC Careers page!

About Us

PTC Therapeutics is a global biopharmaceutical company dedicated to the discovery, development and commercialization of clinically differentiated medicines for children and adults living with rare disorders. PTC is advancing a robust and diversified pipeline of transformative medicines as part of its mission to provide access to best-in-class treatments for patients with unmet medical needs. Our strategy is to leverage our scientific expertise and global commercial infrastructure to optimize value for patients and other stakeholders.

To learn more about PTC, please visit www.ptcbio.com and follow us on LinkedIn, X, Instagram and Facebook.

Please Beware of False Job Advertisements

PTC Therapeutics is aware of employment hiring scams that make false use of our company, leader and employee names to defraud job seekers. PTC does not make job offers without interviews and we never ask candidates for money.If you have encountered a job posting or been approached with a job offer from an email address that does not use ptcbio.com, or that you feel may be fraudulent, we strongly encourage you NOT to respond.