Director, Biostatistics

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Apogee Therapeutics

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Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• We are seeking a Director of Biostatistics. In this position you will function as the statistical lead for one or more studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. • 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.

Requirements

• PhD in statistics strongly preferred; Candidates with MS in statistics or biostatistics and a depth of relevant experience in drug development statistical research will be considered • A minimum of 10 years’ experience in progressive and relevant clinical trial experience • Advanced knowledge of statistical methods in clinical study designs (including adaptive designs, Bayesian methods, and platform trials), statistical analysis methods (such as Bayesian analysis, missing data imputation, and multiplicity adjustment with graphical approaches), and expertise in analyzing continuous, binary, count, and time-to-event data • Strong experience in designing, executing, analyzing, and interpreting simulations, including clinical trial simulations • 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 leading teams and working in a matrix organization • Ability to communicate and collaborate 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 • Ability to keep pace in a fast-moving organization and navigate ambiguity • Experience working with in a remote virtual environment • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Travel to company meetings, conferences, etc. at least 4 – 8 times per year is required

Benefits

• 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 • Flexible PTO • Two, one-week company-wide shutdowns each year • 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