Associate Director, Statistical Programming
Remote
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: C aring, O riginal, R esilient and E goless 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, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office
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: C aring, O riginal, R esilient and E goless
- 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
Associate Director, Statistical Programming
Remote
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: C aring, O riginal, R esilient and E goless 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, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office
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: C aring, O riginal, R esilient and E goless
- 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
