Associate Director, Statistical Programming

🕒 April 2

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

📋 Description

• 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

🎯 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 • 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

🏖️ 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 • 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