Senior Director, Biostatistics

Atavistik Bio

Sr. Director of Biostatistics overseeing statistical support for clinical studies at Atavistik Bio.

Posted 6/24/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $270,000 - $290,000 per yearWebsite

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Hard Skills

biostatisticsstatistical analysisclinical trial designadaptive designBayesian methodsmissing data imputationmultiplicity adjustmentsample size determinationstatistical programmingdata analysis

Soft Skills

leadershipcommunicationcollaborationpresentation skillsproblem-solvingadaptabilityteam managementinterpersonal skillsgrowth mindsetstakeholder engagement

Tools & Technologies

SASRCDISCSDTMADaMclinical trial management systemsdata visualization toolsstatistical softwareregulatory compliance toolssimulation software

Certifications & Qualifications

PhD in statisticsMS in statisticsbiostatisticsmathematics

Industry Keywords

clinical studiesregulatory interactionsFDA guidelinesEMA guidelinesICH guidelinesCRO managementpatient reported outcomesmatrix organizationoutsourced modelclinical trial simulations

About the role

Key responsibilities & impact

acting as the statistical lead for one program or multiple programs
providing technical leadership and statistical support on the design, conduct and execution of the clinical studies
oversight of the statistics and programming team through an outsourced model
partnering closely with the cross-functional teams and providing expert biostatistics input on development plans, regulatory interactions, and study design
authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter
analyzing and interpreting the clinical study results, and ensuring statistical integrity.

Requirements

What you’ll need

PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered
A minimum of 8 years’ experience in progressive and relevant clinical trial experience
Experience leading teams and working in a matrix organization
Experience with blinded study designs and analyzing and interpreting patient reported outcome (PRO) data sets strongly preferred
Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
Experience managing CROs and other data vendors
Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a collaborative work culture
Ability to keep pace in a fast-moving organization and navigate ambiguity
Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment
Knowledge and proficiency in SAS or R and other industry computational tools
Knowledge of CDISC standard including SDTM, ADaM
Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
Experience in planning, running and documenting simulations, including clinical trial simulations
Experience working on site and with remote teams
Ability and willingness to travel up to 10% or as needed by the business

Benefits

Comp & perks

competitive compensation, including equity-based compensation
comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care