Lixin Simon Gao Email & Phone Number

We are a team of experienced biostatistical consultants specializing in biostatistics and programming for clinical trials. Our service is to evaluate drug safety and efficacy and help our BioPharma sponsors seek drug approval from regulatory agencies like FDA. Established in 2006 and based in Boston, we operate 100% in the USA. We have a very loyal team and a loyal client base. Our business is built through the trust gained from years of quality work, and word-of-mouth is the primary driver of our growth. We are a highly productive team, and our team has delivered over 150 clinical trial studies across Rare Diseases, Oncology, GI, CNS, Vaccines, and many other therapeutic areas. We pride ourselves on being the preferred provider for top pharmaceutical companies and have significantly contributed to their (s)NDA/(s)BLA submissions. Our clients like us because of our quality, experience, and ability to deliver.

Listed skills include Cdisc, Sas Programming, Clinical Trials, Edc, and 6 others.

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  President

  Biopier, Llc.

  Jul 2006 - Present - Lexington, Ma, Us

  BioPier is a Boston-based biometrics CRO founded in 2006, 100% USA-based. Our team of experienced biostatisticians and programmers has a proven track record of delivering high-quality studies and (s)NDA/(s)BLA submissions. Our satisfied clients and their referrals are the foundation of our success.BioPier TeamBioPier is a team of experienced biostatistical consultants. Team members have an average of 8+ years of experience working in the pharmaceutical industry; the core team has an average of 15+ years. 35% of our team members have Ph.D. degrees, and 95% have earned an M.S. degree or above. The turnover rate within our team is extremely low. BioPier StrengthAt BioPier, we pride ourselves on our strong reputation for experience and our perfect record of quality on-time delivery. Our clients like us because we are very responsive and easy to work with. BioPier ExperienceSince 2015, we've been awarded contracts for over 150 studies/contracts in Rare Diseases, Oncology, GI, CNS, Vaccines, and many other therapeutic areas. Most of our studies are late-phase studies. Our exceptional performance has made us the preferred provider for top pharmaceutical companies and has significantly contributed to their (s)NDA/(s)BLA submissions. About half of our services follow ongoing studies (Phase 1-4), and the rest support submission work like ISS, ISE, HTA, eCRT, FDA-IR, Legacy-to-CDISC migrations, etc.Examples to showcase our capabilities: From 2019-2022, we helped our clients rescue six pivotal Phase-3 studies. These studies were already at-risk with other CROs, some even in their dry-run stage. We were able to rework them on a very tight schedule and mitigated their risks. BioPier Service ModelBioPier's service model has been project-based and unit-based. We keep our costs low because all sales are from referrals, and we keep a flat and slim reporting structure. The senior staffs directly serve as project managers.