Biostatistician

Job Description

• Collaborating with clinical investigators, sponsor, and cross‑functional teams to determine study design.
• Collaborating with Medical Writing and Project Management teams on protocol development, including writing sections pertaining to statistical input.
• Development of statistical analysis plans and programs to perform analyses and display study data.
• Reviewing protocols and case report forms to ensure that protocol objectives are met and standards are maintained.
• Generating treatment allocations in randomized clinical research studies and ensuring proper implementation.
• Performing statistical analyses; writing and validating application programs, including for centralized monitoring purposes.
• Implementing data and safety monitoring reports to ensure participants’ safety.
• Developing metrics and generating quality control reports to optimize the performance of clinical sites and the coordinating center.
• Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies.
• Participating in professional development activities both within and outside the company.
• Other duties as assigned.

• PhD in biostatistics, statistics, epidemiology or related field.
• Minimum of 3‑5 years of experience in a CRO environment.
• Demonstrated proficiency with statistical methods and applications in clinical research.
• Strong programming skills in SAS and/or R.
• Ability to manage multiple tasks.
• Ability to work independently, as well as in a team environment.
• Ability to effectively communicate technical concepts, both written and oral.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.