Lead statistical programming for clinical trials, manage programming teams and vendors, and ensure high-quality data deliverables in compliance with regulatory standards.
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 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
- Phase 3 and BLA submissions experience preferred
- 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 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 (at least 4 – 8 times per year)
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.
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.
Top Skills
Adam
Cdisc
R
SAS
Sdtm
Apogee Therapeutics Waltham, Massachusetts, USA Office
221 Crescent St , Waltham, MA , United States, 02453
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