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 is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.

We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.

If this sounds like you, keep reading!

Role Summary

We are seeking an Associate Director of Statistical Programming. In this position you will be responsible for leading statistical programming activities to support various clinical trial projects. You will also support building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution of Apogee’s clinical programs. You will manage 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.

Key Responsibilities

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

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 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

The anticipated salary range for candidates for this role will be $190,000-$210,000. 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.

What We Offer

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

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

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.

To review our privacy policy, click here

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Associate Director, Statistical Programming

TLDR