Manager, Biostatistics
Two Tower Place, 12th Floor Rockville, MD 20847 US | Work from home flexibility TELECOMMUTE US
Job Description
Manager, Biostatistics
Industry: Biopharmaceutical
Status: Full Time Employee
Location: Rockville, Maryland (hybrid remote)
THE ROLE YOU WILL PLAY:
• Function as independent project statistician for multiple clinical studies
• Provide evaluations on study design and clinical trial protocols
• Manage Biostatistics and statistical Programming tasks outsourced to vendors
• Support the preparation of regulatory submissions (BLAs/NDAs) with FDA and/or EU
• Perform SAS Programming validation, and statistical analyses for clinical publications
COMPANY FEATURE AND BENEFITS:
• Ultimate goal of making meaningful changes for lives around the globe
• Offering award-winning benefits to their employees including health benefits, salary, annual bonus, vacation and personal time-off, 401 (k)
• Workplace environment that values each contributor as well as their families
• Provides Leadership and Development Programs to promote employees to grow both professionally and personally
YOUR BACKGROUND PROFILE:
• Ph.D. or M.S. degree in Statistics/Biostatistics
• 3 years of industry experience in clinical drug development (sponsor or CRO)
• Knowledge with regulatory submissions with FDA and/or EU
• Comprehensive knowledge of clinical trial methodology, regulatory requirements, and statistical software packages
• Preferred experience in adaptive design including Bayesian approach
• Excellent communication skills, both verbal and written
ABOUT ABA SEARCH
At ABA Search, we value professionalism, honesty, and hard work. We're positive, innovative thinkers, and we use creativity to turn challenges into opportunities. We thrive on deepening our expertise. We're energized by the legal, life science, and pharmaceutical industries, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us "the name to know in recruitment."
Meet Your Recruiter
Denise Levine
Director, Executive Search - Biometrics
Denise joined ABA in 2019, as a Director of Executive Search. She has been working as a Recruiter for the past 16 years, 10 of which have been supporting the Biotechnology and Pharmaceutical industries, specifically in the areas of biometrics and clinical trials. She holds a Bachelor of Arts degree in Psychology from Emmanuel College in Boston, MA. Denise takes pride in developing long-term relationships and is particularly excited about getting to know clients and candidates beyond the job description and the resume. She is passionate about connecting top talent with the right opportunity.
Born and raised in the San Francisco Bay Area, Denise played soccer throughout her youth and also in college. She's currently the Assistant Coach to her son's soccer team. Denise lives in Placer County where she enjoys family time with her husband, two boys, and their chocolate lab, Suzy. She spends her weekends on house projects, gardening, crafting, coaching her son’s soccer team, exploring, spending time with friends and family, and camping.
Favorite things to do in Placer County: Exploring all of the fun activities Placer County has to offer, lake days, and wine tasting
Favorite Quote: "Keep your face always toward the sunshine and shadows will fall behind you." – Walt Whitman