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

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
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
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 typically held twice per year

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

Associate Director, Statistical Programming

Key skills