About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.

We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.

If this sounds like you, keep reading!

Role Summary

We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple projects, providing technical leadership and statistical support on the study design, project planning, conduct and execution of clinical studies, and scientific publications. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to 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.

Key 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

Ideal Candidate

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

The anticipated salary range for candidates for this role will be $195,000 - $225,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

What We Offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
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

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Associate Director, Biostatistics

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