Senior Clinical Biostatistician

Enjoy what you do while contributing to an academically-affiliated medical network that makes a difference in people's lives. US Fertility (USF), the largest network of fertility practices in the United States, continually seeks experienced, compassionate, and dynamic team players who are committed to advancing our field towards improving patient outcomes. The work we do building families offers stimulation, challenge, and personal reward.

US Fertility (USF), the largest network of fertility practices in the United States, continually seeks experienced, compassionate, and dynamic team players who are committed to advancing our field towards improving patient outcomes. The work we do building families offers stimulation, challenge, and personal reward.

The Senior Biostatistician is responsible for assisting the Research Division at USF in both research study design and analysis as well as to provide mentorship of medical students, embryologists, OB/GYN residents, and Reproductive Endocrinology Fellows. Currently the network is affiliated with six university-based fellowship programs (including the REI fellowship based at the NIH) and many more OB/GYN residencies, affording the opportunity for academic appointment(s)/professorship(s). Furthermore, given that USF clinics carry out approximately 20% of the IVF cycles in the U.S., this opportunity offers access to an unparalleled dataset for research, in terms breadth, depth, and accuracy.

Prominent researchers currently carrying out their work at USF, with whom you would closely collaborate include: Alan Copperman MD, Kate Devine MD, Micah Hill DO (SREI immediate past president and current SART vice president), Phill Romanski MD, Kerry Flannagan PhD (USF’s full-time Lead Epidemiologist, based in Rockville, Maryland, with whom our Senior Biostatistician will collaborate closely), Nanette Santoro MD, Bruce Shapiro MD/PhD, Michael Tucker PhD, and Matthew “Tex” VerMilyea PhD. You can find our full team of regional clinical research directors on the USF Research website. This role also offers tremendous authorship opportunities, as well as the potential for academic adjunct faculty appointment(s) at our collaborating academic medical centers.

The USF network is currently comprised of five medical infertility practices: Shady Grove Fertility, Reproductive Science Center of the Bay Area, RMA New York, IVF Florida Reproductive Associates, and Fertility Centers of Illinois. Ovation Fertility (a network of IVF laboratories) has also recently joined USF. USF has a history of impressive clinical research output and publication volume. The network has published more than 100 peer reviewed manuscripts and presents research at multiple national meetings each year. Our research division has conducted many RCTs – NIH, industry, and independently funded, and our researchers have won many awards. The USF Research Division meets regularly and collaborates with physician researchers from within and outside the network. The division has ample administrative support, and many of the practices house internal clinical research teams, including nurses and study coordinators.

· USF oral presentation, “Chromosomal Analysis of Blastocysts Derived from 0 and 1 PN Zygotes” won the 2024 PCRS First Place Outstanding Paper. USF also won first prize PCRS paper in 2023 for “Adding short duration GnRH antagonist and gonadotropin to modified natural cycle frozen embryo transfer allowed scheduling of transfer day without compromising live birth”

· USF researchers presented over 60 abstracts at the 2023 ASRM Scientific Congress.

· Chief Research Officer, Kate Devine, was awarded the prestigious Ira and Ester Rosenwaks New Investigator Award at the 2023 ASRM Scientific Congress for her research contributions over the past decade.

· Shady Grove Fertility recently conducted the Synchrony study, a funded investigator initiated randomized controlled trial evaluating whether timing of euploid frozen embryo transfer according to endometrial receptivity assay improves live birth outcomes. Findings were published in JAMA in December 2022. · The division completed an investigator initiated, funded, randomized controlled trial comparing routes of progesterone replacement for frozen embryo transfer that was awarded 2018 Scientific Congress Prize paper by the ASRM and was a “Seminal Contribution” to Fertility and Sterility.. · The division is currently the lead enrolling site for the NatPro study, an NIH funded RCT, seeking to elaborate the best protocol for frozen embryo transfer, in terms of maternal-fetal health. SGF is collaborating with Hopkins, Penn, and Stanford and is the lead enrolling site on this multicenter, NIH funded RCT.

We have an immediate opening for a full-time Senior Clinical Biostatistician to join our team. The schedule is Monday through Friday, from 8:00 am until 5:00 pm in our Rockville, MD or Remote Office.

How You'll Contribute: We always do whatever it takes, even if it isn’t specifically our “job.” In general, the Senior Clinical Biostatistician is responsible for:

Responsibilities include:

• Lead interdisciplinary, cross-functional project teams in the development and implementation of research projects to accomplish specific scientific goals; lead or contribute to research study design, project management, data collection and analysis, and dissemination and reporting.
• Develop, oversee, and manage core research documents, including study protocols, standard operating procedures, study specific training materials, and Institutional Review Board (IRB) compliance and other institutional/agency regulatory documents. Ensure studies are conducted in compliance with the respective investigational plan/protocol and all applicable regulations, IRB requirements, and other institutional policies and procedures.
• Conduct literature reviews, consult with internal and external experts, and participate in formal development opportunities to inform project ideation and to stay abreast of evidence-based best practices and clinical guidelines, research methods and techniques, regulatory requirements, and innovation in healthcare delivery.
• Lead and contribute to research project activities including: development and testing of primary data collection tools; study recruitment, participant enrollment/consent and data collection; subject randomization; extraction of secondary data from electronic medical records; and data cleaning and analysis.
• Organize and update multiple large datasets.
• Write reports, memos, abstracts, and peer-reviewed manuscripts for publication, and prepare presentations that provide recommendations for clinical practice.
• Provide research mentoring and assistance to our large group of network medical fellows and residents.
• Orchestrate and plan network research committee meetings.
• Supervise, direct, and evaluate project staff as needed.

Other duties as assigned and deemed necessary within the scope of the Sr. Corporate Analyst role.

What You'll Bring:

The skills and education we need are:

• PhD. in Biostatistics, Epidemiology, Public Health, Reproductive Biology, or related health field. Master’s degree considered.
• 7+ years' of progressive responsibility in managing clinical or health services research programs in clinical, academic, or healthcare setting.
• 2+ years' experience as an investigator developing and leading research projects.
• 2+ years' experience writing and publishing research articles in peer reviewed journals.
• Expertise in study design for clinical research and of appropriate statistical analysis of prospective and retrospective clinical data.
• Enthusiasm and dedication to answering relevant clinical research questions in Reproductive Biology, Reproductive Endocrinology and Infertility.

More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful.

What We Offer:

• Competitive pay + bonus
• Comprehensive training
• Medical, dental, vision, and 401(k) matching
• Generous paid time off and holidays
• Tuition assistance
• Ability to make an impact in the communities we serve