Director, Statistical Programming
December 4
Description
• We are seeking a Director of Statistical Programming, reporting to the Head of Statistical Programming. • You will be responsible for developing and maintaining statistical programming functions within the therapeutic area to support various clinical trial projects, medical affairs, pharmacovigilance and other functions. • You will manage statistical programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams.
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
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
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