Director, Statistical Programming

Summary

Join Apogee Therapeutics as their Director of Statistical Programming! Reporting to the Head of Statistical Programming, you will lead the statistical programming function, manage programming activities, and collaborate with cross-functional teams. You will develop programming processes, review datasets, and build and mentor a team of programmers. This hands-on role requires a Master's degree, 10+ years of experience in clinical trial programming, advanced SAS skills, and strong leadership abilities. 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 STDM, 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
• Advanced knowledge of state-of-art statistical programming methods in clinical study setting
• Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance
• Create data and documents necessary to support an electronic submission in the eCTD format
• Experience working with in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel per business needs

Responsibilities

• Lead statistical programming function within the therapeutic area to support clinical trials by developing and implementing programming processes, programming standards and SOPs
• Effectively manage programming activities on projects and studies and oversee CROs
• 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
• Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs
• Develop SAS programming infrastructure and programming processes to enable efficient data deliverables and ad hoc analyses
• Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities
• Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs 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

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