Senior Director, Biostatistics
PTC Therapeutics, Inc.
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 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.
Job description
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.
Essential Functions
- 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%
Requirements
- Advanced degree in Statistics or a related statistical discipline
- 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 in a fast-paced, matrixed, team environment
- 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
- Thorough/detailed understanding of regulatory requirements and guidance documents
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Retirement savings plans
- Short-term incentives
- Long-term incentives
Company overview
PTC Therapeutics, Inc. is a patient-centered biopharmaceutical company founded in 1998 and headquartered in Warren, New Jersey. The company specializes in discovering, developing, and commercializing innovative medicines for children and adults living with rare and serious diseases. PTC focuses on orally administered small molecule drugs and gene therapies that regulate gene expression by targeting post-transcriptional control mechanisms. The company's therapeutic areas include orphan and ultra-orphan disorders, oncology, and anti-infectives, with a particular emphasis on genetic disorders affecting metabolism and neurology. PTC's commercialized products include treatments for Duchenne muscular dystrophy, aromatic L-amino acid decarboxylase deficiency, spinal muscular atrophy, and other rare conditions. The company operates globally with a dedicated team of approximately 939 employees and maintains a robust pipeline of investigational therapies. PTC is publicly traded on NASDAQ under the symbol PTCT and has established itself as a leader in rare disease therapeutics through its commitment to scientific innovation and patient-focused approach.