Associate Director, Statistical Programming

Summary

Join Apogee Therapeutics as an Associate Director of Statistical Programming and lead statistical programming activities for various clinical trial projects. You will oversee programming vendors, review datasets, collaborate with cross-functional teams, and develop programming processes. This role requires managing programmers, generating ad-hoc analyses, and ensuring timely delivery of high-quality data deliverables. The ideal candidate possesses a Master's degree in a relevant field, 10+ years of experience in clinical trial programming, advanced SAS programming skills, and strong leadership qualities. Apogee offers a competitive compensation and benefits package, including a great culture, flexible PTO, and professional development opportunities.

Requirements

• Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
• A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry
• Advanced SAS programming skills and experience in other statistical software, such as R, etc
• Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
• Excellent organizational skills and ability to prioritize tasks
• Excellent communication and interpersonal skills
• 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
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 10% including a minimum of 4 times per year for company

Responsibilities

• Serve as a lead statistical programmer on one or more clinical studies
• Provide statistical programming oversight to programming vendors
• Review and validate datasets and TFLs programmed by vendors
• Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
• Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
• Participate in developing and implementing statistical programming processes and standards
• Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
• Build and mentor a team of programmers to support clinical trials and pipelines
• Generate ad hoc analyses on ongoing basis

Preferred Qualifications

• Advanced knowledge of state-of-art statistical programming methods in clinical study setting
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience working with in a remote virtual environment

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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