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Apogee Therapeutics · 3 days ago

Associate Director, Biostatistics

United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$195K/yr - $215K/yr

8+ years exp

Apogee Therapeutics is a biotechnology company focused on developing differentiated biologics for treating inflammatory and immunology conditions. They are seeking an Associate Director of Biostatistics to provide technical leadership and statistical support on clinical studies, ensuring statistical integrity and collaborating with cross-functional teams.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

Contributor on regulatory submissions

Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies

Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations

Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks

Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies

Evaluate alternative or innovative approaches to statistical methods and study design

Build relationships with CROs and other external partners to achieve results for specific project needs

Ensure the delivery of high quality and timely reports to project teams and clinical trial team

Qualification

PhD in statisticsClinical trial experienceStatistical methodsSASR proficiencyCDISC standards knowledgeRegulatory guidelines knowledgeCRO managementTeam leadershipCommunication skillsGrowth mindset

Required

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 with phase 3 study and regulatory submission is preferred

Experience leading teams and working in a matrix organization

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 psychologically safe environment

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 missing data imputation, multiplicity adjustment, estimand, Bayesian method, etc

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 in a remote virtual environment

Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless

Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office

Preferred

Experience with phase 3 study and regulatory submission is preferred

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

Commitment to growing you professionally and providing access to resources to further your development

Apogee offers regular all team, in-person meetings to build relationships and problem solve

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)