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Senior Director, Biostatistics - Medical Affairs & Real World Evidence

Company: PTC Therapeutics
Location: Plainfield
Posted on: September 17, 2020

Job Description:

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* Travel requirements: 5- 15%

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Senior Director Biostatistician Jobs in South Plainfield, NJ. Jobs. Jobs. Interviews. PTC Therapeutics3.2?. Senior Director, Biostatistics - Medical Affairs & Real World Evidence. Actively HiringPTC Therapeutics is actively hiring for this role. Apply now!. Job. Company. Rating. Reviews. Why Work With Us. Location. Job Description Summary:. The Senior Director leads the Biostatistics and Statistical Programming team for Medical Affairs and Real World Evidence-related activities. The position provides strategic statistical leadership and operational oversight for the design, implementation and interpretation of post approval clinical trials and program and disease registries. He/she works collaboratively with the medical affairs organization to develop and execute publication plans and serves as the liaison to the global market access and health economics teams. The incumbent may interact with regulatory agencies on matters related to the data for clinical programs and/or trials.. He/She manages direct reports and 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:. Ensures the timeliness and quality of statistical deliverables for clinical trial and registry results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material.. Develops solutions to statistical and data analysis 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 for clinical studies and registries.. Authors and manages the implementation of statistical analysis plans, defining data analysis strategies, interpreting the resulting 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.. Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as needed.. Manages, coaches and mentors direct reports.. Performs other tasks and assignments as needed and specified by management.. Qualifications:. Advanced degree in Statistics or a related statistical discipline and a minimum of 9 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 and key opinion leaders.. Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry.. Demonstrated, applied experience supporting Phase 4 clinical trials and/or the medical affairs function.. Prior experience managing direct reports and leading a team.. 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. Prior BLA, NDA and/or MAA experience is highly desirable. 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.. Click here to return to the careers page. Get alerts to jobs like this, to your inbox.. Glassdoor has millions of jobs plus salary information, company reviews, and interview questions from people on the inside making it easy to find a job that’s right for you.

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Keywords: PTC Therapeutics, Plainfield , Senior Director, Biostatistics - Medical Affairs & Real World Evidence, Other , Plainfield, New Jersey

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