Remote, Oregon

Job Description Summary:

The Director, Biostatistics -Medical Affairs and Real-World Evidence provides technical leadership and operational support for the design, implementation and interpretation of post approval clinical trials, programs, and disease registries.

The incumbent works collaboratively with the medical affairs organization to develop and execute publication plans and to provide support to the global market access and health economic teams. The incumbent may interact with regulatory agencies on matters related to the data for clinical programs and/or trials.

The Director, Biostatistics - Medical Affairs and Real-World Evidence ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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Job Description:

  • Ensures the timeliness and quality of statistical deliverables for clinical trial and registry results, exploratory and meta-analyses, publication activities, and scientific presentations.
  • Develops solutions to statistical and data analysis issues for clinical issues for regulatory, medical affairs, market access, and commercial teams. Communicates solutions cross-functionally.
  • Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
  • Authors and manages the implementation of statistical analysis plans, defining data analysis strategies, interpreting the result findings, and crafting and communicating key messages to internal audiences and selected key external stakeholders.
  • Defines data analysis and mining strategies for natural history databases.
  • Participates in vendor evaluation, selection, and management.
  • Performs other tasks and assignments as needed and specified by management.

Qualifications:

* Minimum level of education and years of relevant work experience.
  • Advanced 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.

* 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 and key opinion leaders.
  • 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.
  • 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.
  • Excellent understanding of regulatory requirements and guidance document.
  • Prior BLA, NDA and/or MAA experience is highly desirable.

Travel Requirements: 5- 15%

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

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.

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Remote, Oregon

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare disease.

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