Job description

Responsibilities

· At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements.

• Provide statistical support to Clinical Development Plan for multiple compounds
• Participate in pre-IND and NDA/BLA activities
• At study level, provide statistical input to study protocols, develop statistical analysis plan
• Assist in writing relevant sections of the clinical study report and publication
• Monitor internal and CRO project activities including timelines, deliverables and resources
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
• Develop and implement department standards and lead process improvements

Minimum Requirements

• PhD or MS in Biostatistics or Statistics;
• At least 1 year of experience as statistician in Pharmaceutical or Biotechnology industries;
• Candidate with Intern experience in the pharmaceutical industry will be considered
• Good knowledge of statistical programming languages (including SAS, R);
• Solid oncology and/or hematology experience
• Experience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissions
• Experience as an independent lead statistician with responsibility for multiple studies or projects
• Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively;
• Knowledge of SDTM/ ADAM

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Contract, Temporary

Pay: $100,000.00 - $250,000.00 per year

Benefits:

• Dental insurance
• Health insurance

Schedule:

• 8 hour shift

Work Location: Remote

gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.