Senior Director, Biostatistics

ptcbio; New Jersey; Hybride; USD 239 000 - 281 000; Plein temps

Avantages offerts par ce poste

Short- and long-term incentives

Medical, dental, vision coverage

Retirement savings plans

Résumé du poste

PTC Therapeutics is seeking a Senior Director, Biostatistics to provide technical leadership and oversight for clinical development programs across assigned therapeutic areas.

The role involves designing studies, defining data analysis strategies, authoring analysis plans, and communicating findings to internal teams and key external stakeholders. Interaction with regulatory agencies is possible.

Qualifications

• 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

Responsabilités

• 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.

Connaissances

Clinical statistics

Regulatory interaction

Cross-functional collaboration

Communication skills

Problem solving

Formation

Advanced degree in Statistics

Description du poste

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).
• 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.

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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.