• Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials
• Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards
• Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables
• Manage and oversee CROs and external vendors to ensure quality and compliance with expectations
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions
• Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams
• Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs
• Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input
• Mentor and develop programmers, fostering a high-performing and collaborative team environment
• Provide hands-on support for complex analyses and ad hoc requests as needed
• Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows

Ideal Candidate

• Master’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
• A minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experience
• Advanced SAS programming skills: experience with R or other statistical programming languages preferred
• Strong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminology
• Experience supporting regulatory submissions (e.g., NDA/BLA/MAA)
• Knowledgeable in AI use in drug development and ambitious in leveraging AI to build infrastructure/workflows to expedite submission process
• Excellent organizational skills with the ability to manage multiple priorities
• Strong communication and interpersonal skills, with the ability to collaborate cross-functionally
• Experience managing CROs and external data vendors
• Demonstrated ability to mentor team members and contribute to team development
• Advanced knowledge of statistical programming methodologies in clinical study settings
• Knowledge of ICH guidelines and FDA / EMA / other regulatory authority requirements
• Experience working in a fast-paced, growth-oriented environment
• Experience working in a remote/virtual environment
• Experience with AI-driven tools or automation in clinical data analysis and regulatory submission processes (e.g., AI-assisted generation, validation, or review of submission deliverables)
• Familiarity with modern data platforms, cloud environments, or scalable analytics infrastructure
• Experience in a small to mid-size biotech environment
• Strong leadership with a collaborative and growth-oriented mindset
• High attention to quality and detail
• Adaptability and ability to operate effectively in a fast-moving environment
• Commitment to fostering a psychologically safe and inclusive team culture
• Alignment with 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 $270,000 - $295,000. 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.

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.

We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple projects, providing technical leadership and statistical support on the study design, project planning, conduct and execution of clinical studies, and scientific publications. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity.

Key Responsibilities

• Contributor on regulatory submissions
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
• Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and clinical trial team

Ideal Candidate

• PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered
• A minimum of 8 years’ experience in progressive and relevant clinical trial experience
• Experience with phase 3 study and regulatory submission is preferred
• Experience leading teams and working in a matrix organization
• Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
• Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
• 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 and navigate ambiguity
• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including missing data imputation, multiplicity adjustment, estimand, Bayesian method, etc.
• Knowledge and proficiency in SAS or R and other industry computational tools
• Knowledge of CDISC standard including SDTM, ADaM
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience in planning, running and documenting simulations, including clinical trial simulations
• Experience working 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 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 $195,000 - $225,000/ year. 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.