Published: Fri, 21 Feb 2025 02:51:09 GMT
Position: Associate Director, Statistical Programming
Company: Apogee Therapeutics, Inc.
Location: [insert location]
Salary Range: $185,000-$205,000
About Apogee Therapeutics, Inc.
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed biotechnology company focused on developing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We are committed to reshaping the current standard of care for inflammatory and immune diseases, because we believe people living with these diseases deserve the best possible treatment.
Role Summary
Apogee Therapeutics, Inc. is seeking an experienced and highly motivated Associate Director of Statistical Programming to join our team. In this role, you will be responsible for leading statistical programming activities to support various clinical trial projects and building programming processes for clinical studies and submissions. You will manage programmers and CROs, oversee programming activities, and provide timely support to cross-functional teams. The ideal candidate will have a Master’s degree in Statistics, Biostatistics, Mathematics, Epidemiology, or related disciplines and a minimum of 10 years’ experience in progressive and relevant clinical trial programming in the biotech/pharma industry.
Key Responsibilities
– Serve as the lead statistical programmer for one or more clinical studies
– Provide oversight to programming vendors
– Review and validate datasets and TFLs programmed by vendors
– Collaborate with cross-functional teams to deliver high-quality data deliverables in a timely manner
– Develop and implement data review/reporting tools and other statistical applications
– Participate in developing and implementing statistical programming processes and standards
– Review study documents and provide expert feedback
– Build and mentor a team of programmers
– Generate ad hoc analyses
– Travel up to 10% for company meetings and events
Ideal Candidate
– Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
– Minimum of 10 years’ experience in progressive and relevant clinical trial programming in the biotech/pharma industry
– Advanced SAS programming skills and experience with other statistical software
– In-depth knowledge of CDISC including SDTM, ADaM, and controlled terminologies
– Excellent organizational, communication, and interpersonal skills
– Experience managing CROs and other data vendors
– Strong leadership skills and a growth mindset
– Knowledge of state-of-the-art statistical programming methods in a clinical study setting
– Familiarity with ICH guidelines and FDA/EMA/other regulatory authority guidance
– Experience working in a remote virtual environment
– Commitment to Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
What We Offer
– A great company culture, grounded in our C.O.R.E. values
– Competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, and health, welfare & retirement benefits
– Flexible PTO and two, one-week company-wide shutdowns each year
– Opportunities for professional growth and development
– 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 Therapeutics, Inc. participates in E-Verify.
Apogee Therapeutics, Inc. 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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