Biomedical Statistical Consulting® is looking for an incredible Biostatistician to join our company and support our mission of providing best-in-class statistical services to our clients and partners. We are passionate about delivering high value and assisting Sponsors with statistical needs in regulatory Clinical trials.

Biostatistician Purpose

As a Biostatistician at BSC™, you will lead projects with mentorship from senior staff to deliver the project statistician tasks/responsibilities. You will be involved with designing and analyzing medical devices and biological clinical trials.

Successful candidates will work on regulatory submissions and directly contribute to Company success by increasing the strength of study designs, interpretability of results, and facilitating collaboration with internal and external teams.

Essential Duties

  • Apply knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research.

  • Develop and reviews statistical analysis plans based on study-specific documents and sound statistical methodology.

  • Develop, maintain, and produces statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.

  • Interact with the sponsor, internal, and external team members.

  • Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation. Provide guidance for database structures for analysis.

  • Provide randomization schemes and appropriate documentation.

  • Programs/validate statistical tables with an emphasis on efficacy endpoints. Provide proper documentation and oversees the work of others who assist in programming/validating.

  • Understand and comply with all company policies and standard operating procedures.

  • Maintain a professional working relationship with sponsors, collaborating associates, and vendor personnel.

Education and Experience

  • Ph.D. with 1-3 years experience, or a Master's degree with 3-5 years experience in Biostatistics, Statistics, or a similar field.

  • 3+ years CRO experience.

  • Lead Experience.

Required Knowledge Skills and Abilities

  • Knowledge of FDA and ICH Guidelines required.

  • Knowledge of statistical design, analysis, and programming techniques utilized in clinical research required.

  • Good SAS® programming skills and understanding of database structures

  • Ability to work on multiple projects at once

  • Sense of ownership and pride in your performance and its impact on the company's success

  • Good time-management skills

  • Excellent interpersonal, written, and oral communication skills.

Working Conditions/Physical Demands

While performing the duties of this job, the employee must be able to :

  • Maintain an excellent work ethic and the willingness to work additional hours as needed.  

  • Travel occasionally.  

  • Perform light work – exerting up to 20 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.     

  • See, hear, talk and perform tasks requiring manual dexterity and visual acuity; kneel, sit, stand, walk, crouch, stoop, reach, pull, push and other similar, repetitive tasks requiring physical activity.   

  • Operate standard office/computer equipment.  

Equal Opportunity Employer

The Company is an equal opportunity employer. We value a diverse workforce and an inclusive culture. We encourage applications from all qualified individuals and do not discriminate, and will not tolerate discrimination, on the basis of race, ethnicity, color, religion, sex, pregnancy, gender, gender identity or expression, national origin, sexual orientation, age, national origin or ancestry, genetic information, political affiliation, physical or mental disability, military or veteran status, or any other protected status under federal, state or local law.  Our employment decisions are solely made according to qualifications for the positions.