Job description
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.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.
If this sounds like you, keep reading!
Role Summary
We are seeking an Associate Director, Clinical Programming, to join the Data Management team. In this position you will be responsible for both managing and analyzing clinical trial data using programming languages like SAS, R, and Python to ensure data integrity, generate tables and figures, and support regulatory submissions. Key responsibilities include data cleaning, developing statistical programs, creating reports, validating outputs, and collaborating with statisticians and data managers to assess drug safety and efficacy. Ensure compliance with CDISC standards and regulatory guidelines to support decision-making.
Key Responsibilities
- Clean, validate, and transform raw clinical trial data from various sources into standardized formats, such as CDISC SDTM
- Participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
- Develop and execute SAS programs (or other languages like R/Python) to create datasets, tables, listings, and figures (TLFs) as specified in the Statistical Analysis Plan (SAP)
- Responsible for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed
- Work closely with CROs to prepare and ensure proper development and execution of data management activities
- Review protocols to ensure database feasibility
- Perform statistical analyses support for the efficacy and safety evaluation of treatments
- Perform quality control (QC) checks on vendor programming work, including SAS code and generated outputs, to ensure accuracy and adherence to standards
- Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
- Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion, and to design analyses, interpret results, and solve programming challenges
- Ensure all programming and data activities comply with Good Clinical Practice (GCP) and regulatory agency guidelines
- Maintain comprehensive documentation of programming work for audit trails and regulatory submissions
- Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
- Build and mentor a team of programmers(s) to effectively support clinical trials and pipeline
Ideal Candidate
- Bachelor’s Degree in a position relevant field, such as statistics, computer science, or scientific discipline preferred
- Minimum of 8 to 10 years of clinical programming in pharma/biotech industry
- Direct people management experience in a remote setting is a plus
- Late-stage regulatory submission experience (NDA, sNDA and BLAs) highly preferred
- Proficiency in statistical programming languages such as SAS
- Technology proficiency includes Data Management Systems
- Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality
- Familiarity with clinical data standards like CDISC SDTM and CDISC
- Extensive experience managing CROs and other data vendors
- Strong analytical and problem-solving skills to identify and resolve data issues
- Knowledge of Good Clinical Practice
- EDC and eCOA experience (Medidata, Veeva, etc.)
- Understanding of clinical trial design, protocols, and regulatory requirements
- Ability to keep pace in a fast-moving organization and navigate ambiguity
- Ability to communicate effectively with both technical and non-technical team members
- Meticulous attention to detail is crucial for data accuracy and consistency
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- Ability and willingness to travel 10-15% or as needed by the business
The anticipated salary range for candidates for this role will be $185,000-$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
- 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
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.
A pogee 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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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.
