Associate Director, Statistical Programming
Remote
Apogee Therapeutics is a clinical‑stage biotechnology company advancing novel biologics for the treatment of atopic dermatitis, asthma, and other indications. The company’s most advanced program, Zumilokibart (APG777), is designed to overcome limitations of existing therapies through advanced antibody engineering.
Role Summary
We are seeking an Associate Director of Statistical Programming to lead programming activities across multiple clinical trial projects. The role involves managing programmers and CROs, overseeing programming vendor work, and supporting cross‑functional teams with timely, high‑quality statistical programming deliverables.
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.
- Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high‑quality data deliverables promptly.
- Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications.
- Participate in developing and implementing statistical programming processes and standards.
- Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and provide expert feedback.
- Build and mentor a team of programmers to support clinical trials and pipelines.
- Generate ad hoc analyses on an ongoing basis.
Ideal Candidate
- Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines.
- Minimum of 10 years progressive clinical trial programming experience in biotech/pharma.
- Advanced SAS programming skills and experience with other statistical software such as R.
- In‑depth knowledge of CDISC, including SDTM, ADaM and controlled terminologies.
- Excellent organizational skills and ability to prioritize tasks.
- Strong communication and interpersonal skills.
- Experience managing CROs and other data vendors.
- Leadership qualities with a growth mindset, promoting a psychologically safe environment.
- Ability to keep pace in a fast‑moving organization.
- Advanced knowledge of state‑of‑the‑art statistical programming methods in a clinical study setting.
- Knowledge of ICH guidelines, FDA/EMA and other regulatory authority guidance.
- Experience working in a remote virtual environment.
- Demonstrated alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, Egoless.
- Position requires up to 15% travel, including mandatory in‑person attendance at All Hands meetings 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 factors such as experience, education, and geography.
What We Offer
- A great culture grounded in our C.O.R.E. values: Caring, Original, Resilient, Egoless.
- Opportunity to work in a fast‑paced, highly dynamic environment and shape the company culture.
- Market‑competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Competitive time off, including three weeks PTO, two company‑wide shutdowns per year, and dedicated paid sick leave.
- Commitment to your professional growth with access to development resources.
- Regular all‑team in‑person meetings to build relationships and solve problems.
E‑Verify Participation: Apogee participates in E‑Verify as part of the I‑9 verification of authorization to work in the U.S.
Equal Opportunity
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.
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.
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