Director, Biostatistics

PTC Therapeutics • Warren, MI

10h

About The Position

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 Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds. This includes but is not limited to: identifying optimal study designs, defining data analysis strategies, implementing statistical analysis plans, 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 Director, Biostatistics, ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

• 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.
• 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.

Nice To Haves

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director