Senior Manager, Biostatistics

PTC Therapeutics, Inc.; New Jersey; Sur place; USD 148 000 - 180 000; Plein temps

Résumé du poste

PTC Therapeutics, Inc. is seeking a Senior Manager, Biostatistics to lead statistical design and analysis for clinical programs. You will define study designs, analyze data, and craft messages for internal and external stakeholders.

The role requires collaboration across functions, interaction with regulatory agencies, and adherence to SOPs, with 25% travel and a strong emphasis on timely, high-quality deliverables.

Qualifications

• PhD or MSc in statistics or related field with extensive pharma/CRO experience.
• Strong programming in SAS and/or R; statistical methodology and analysis plans.
• Experience interacting with regulatory agencies and preparing study reports.

Responsabilités

• Ensure timely, high-quality statistical deliverables for trials and analyses.
• Develop statistical analysis plans and study designs; review CRFs and data quality.
• Collaborate with cross-functional teams and regulatory bodies; manage vendor relationships.

Connaissances

Independent work

Analytical thinking

Time management

Regulatory knowledge

Formation

PhD in Statistics

MS in Statistics

Outils

SAS

R

Microsoft Office

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 Manager, Biostatistics provides technical 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, 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 Manager, Biostatistics supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

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.
• 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.
• 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.

• PhD in Statistics or related statistical discipline and a minimum of 6 years of statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment OR Master's degree in Statistics or related statistical discipline and a minimum of 8 years of statistical experience in a pharmaceutical, biotechnology, CRO or related environment.

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

• Hands-on experience supporting clinical studies and 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.
• Hands-on statistical programming skills using SAS and/or R.
• Proficiency with 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.
• Special knowledge or skills and/or licenses or certificates preferred.
• Excellent understanding of regulatory requirements and guidance documents.

Travel requirements

• Up to 25%

Expected Base Salary Range: $147,600 - $180,000. 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.

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.