Director, Statistical Programming

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking a Director of Statistical Programming, reporting to the Head of Statistical Programming. In this position 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 and for building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution for Apogee’s clinical programs. In this role, you will also develop statistical programming strategies, SAS programming infrastructure as well as department standards, applications and processes. You will manage statistical programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests. This role will be hands-on as well as building the statistical programming team within the therapeutic area.

Key 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

Ideal Candidate

• 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

The anticipated salary range for candidates for this role will be $225,000-$250,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

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What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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