A Biostatistician conducts statistical analysis of health and biology-related data. Analysis may be used for product development at a pharmaceutical company, disease research at a hospital or health policy research at a public health organization.
Senior Biostatistician TCM Groups, Inc. Boston, MA Job Details Full-time $150,000 - $200,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications FDA submissions Mandarin Teamwork Biostatistics-based research SAS Data imputation R English SAS language Survival analysis Master's degree ICH guidelines Statistics research Pharmaceutical company experience Master of Science CDISC standards Communication with regulatory authorities for clinical trials Biostatistical modeling Full Job Description About TCM Groups, Inc. Founded in 2003, TCM Groups, Inc. is a biometrics-focused CRO serving innovative small- and mid-sized pharmaceutical and biotechnology companies. Operating across the US and China, we provide biostatistics, statistical programming, data management, medical writing, pharmacovigilance, and clinical pharmacology services with extended global coverage hours. We are deliberately right-sized — resourceful, agile, and responsive. Our statisticians work directly with sponsors on development strategy rather than sitting behind a ticket queue. Combined with our flat-fee budgeting model, this is what our clients mean when they say, "Simply, they are different!" Position Summary We are establishing our Boston and New Jersey presence and seeking an experienced Senior Biostatistician to serve as lead statistician across a portfolio of studies — from protocol design through NDA/BLA submission — and as a primary scientific point of contact for sponsors. This is a senior individual-contributor role with real strategic influence, client ownership, and the opportunity to shape statistical standards as our US team grows. Responsibilities Serve as lead statistician on assigned studies and programs, owning statistical deliverables end to end from protocol concept through submission and publication. Provide statistical leadership in protocol development: endpoint selection, estimand framework, randomization and stratification design, sample size and power calculations. Author and own Statistical Analysis Plans (SAPs), TFL shell specifications, randomization specifications, and the statistical sections of protocols and CSRs. Design and execute interim analyses, adaptive and group sequential designs, and futility assessments; serve as independent (unblinded) statistician to
DSMB/DMC
as required. Lead blinded data review and pre-lock data quality assessment in partnership with Data Management. Direct and quality-review the work of statistical programmers on SDTM/ADaM datasets and TFL deliverables; review define.xml, ADRG/SDRG, and Pinnacle 21 output for submission readiness. Support IND, NDA/BLA, and MAA submissions, including ISS/ISE and integrated summaries, and draft statistical responses to health authority questions. Participate in and prepare sponsors for regulatory meetings (e.g., FDA Type B/C, pre-NDA); communicate on the sponsor's behalf regarding statistical methodology, protocol amendments, and endpoint changes. Provide statistical consulting on sponsors' overall development and regulatory strategy. Contribute statistical content to CSRs, manuscripts, abstracts, and conference presentations. Support business development with scientific input into proposals, budgets, and bid defenses. Mentor junior statisticians and contribute to departmental SOPs, standards, and templates. Qualifications Education. MS or PhD in Biostatistics, Statistics, or a closely related quantitative discipline. Experience. Minimum 10 years of biostatistics experience in the pharmaceutical, biotechnology, or CRO industry, including substantial experience as lead study statistician. Regulatory. Strong working knowledge of ICH E6(R3), ICH E9 and E9(R1) (estimands), and FDA/EMA guidance. Demonstrated contribution to at least one completed regulatory submission (IND, NDA, BLA, or MAA) is required. Technical. Advanced SAS (Base, STAT, Macro) required; R strongly preferred. Proficiency with sample size software (East, nQuery, or equivalent). Solid command of CDISC SDTM/ADaM standards and submission deliverables. Methodology. Depth in survival analysis, longitudinal and mixed models, categorical data methods, missing data handling, and multiplicity adjustment. Experience with adaptive, Bayesian, group sequential, or dose-finding designs is a strong advantage. Language. Fluent written and spoken English is required — this role involves direct sponsor communication, regulatory correspondence, and authorship of submission documents. Professional working proficiency in Mandarin Chinese is preferred, given daily collaboration with our China-based teams, but is not required. Working Style. Comfortable with autonomy in a lean, fast-moving organization; able to carry multiple studies and competing timelines without loss of rigor; credible and composed in front of sponsors and regulators. Preferred Qualifications Experience in oncology, rare disease, neuroscience, or cell & gene therapy. Prior CRO experience with direct sponsor-facing responsibility. Prior service as independent statistician to a
DSMB/DMC.
Familiarity with NMPA requirements or China-US bridging strategy. Experience with real-world data or external control arms. Compensation & Benefits Base salary range: $150,000 - $200,000 per year, commensurate with experience, education, and qualifications. Performance bonus; medical, dental, and vision coverage; 401(k); paid time off. Flexible hybrid schedule based out of Greater Boston. How to Apply Send your CV and a brief cover note to , subject line: "Senior Biostatistician - Boston." TCM Groups, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic. Short version for LinkedIn / job boards Senior Biostatistician — Boston, New Jersey (Hybrid) — TCM Groups, Inc. — $150,000-$200,000 TCM Groups is a biometrics-focused CRO (est. 2003) supporting innovative small- and mid-cap biotech and pharma across the US and China. We are building our Boston team and hiring a Senior Biostatistician to lead studies from protocol design through NDA/BLA submission.
You will:
own SAPs, TFL shells, sample size and interim analyses; direct SDTM/ADaM and TFL deliverables; support DSMB/DMC and FDA interactions; and act as a scientific partner to sponsors.
You bring:
MS/PhD in Biostatistics or Statistics; 10+ years in pharma/biotech/CRO as a lead study statistician; advanced SAS (R preferred); ICH E9(R1) and CDISC fluency; completed submission experience. Fluent English required; Mandarin a plus.
Why us:
right-sized and agile, genuine ownership, direct sponsor contact, broad therapeutic exposure.
Pay:
$150,000.00 - $200,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance
