Senior Director, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist the statistical programming function by establishing programming processes, standards, and SOPs for clinical trials.

• Play a role in the creation and upkeep of SAS programming infrastructure, processes, and data standards.

• Lead programming efforts for assigned projects and studies (e.g., spearheading submissions), ensuring deliverables are timely and of high quality.

• Oversee and manage CROs and external vendors to guarantee quality and adherence to expectations.

• Work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other departments.

• Create and implement data review, reporting tools, and statistical applications in collaboration with cross-functional teams.

• Review and validate SAS programs (SDTM, ADaM, and TFLs) produced internally or by CROs.

• Examine SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming insights.

• Mentor and nurture programmers, cultivating a high-performing and collaborative team atmosphere.

• Offer hands-on assistance for complex analyses and ad hoc requests as required.

• Propel process enhancements and efficiencies, including the integration of automation and AI-based solutions in programming workflows.

⛳️ Requirements

• Master’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline.

• At least 12–15 years of progressive experience in clinical trial programming within the biotech/pharma sector, including leadership roles.

• Proficient SAS programming skills; experience with R or other statistical programming languages is preferred.

• Extensive experience and thorough knowledge of CDISC standards (SDTM, ADaM) and controlled terminology.

• Experience in supporting regulatory submissions (e.g., NDA/BLA/MAA).

• Familiar with the application of AI in drug development and eager to utilize AI to construct infrastructure/workflows that expedite the submission process.

• Exceptional organizational abilities with a capacity to manage multiple priorities.

• Strong communication and interpersonal skills, with the capability to collaborate effectively across functions.

• Experience in managing CROs and external data vendors.

• Proven ability to mentor team members and contribute to team growth.

• Advanced understanding of statistical programming methodologies within clinical study contexts.

• Knowledge of ICH guidelines and requirements from FDA / EMA / other regulatory authorities.

• Experience in a fast-paced, growth-oriented environment.

• Experience in a remote/virtual setting.

• Familiarity 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).

• Knowledge of modern data platforms, cloud environments, or scalable analytics infrastructure.

• Background in a small to mid-sized biotech setting.

• Strong leadership qualities with a collaborative and growth-focused mindset.

• High attention to quality and detail.

• Ability to adapt and function effectively in a fast-paced 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 necessitates up to 15% travel, including mandatory in-person attendance at All Hands meetings typically held twice a year.

🏝️ Benefits

• A vibrant culture rooted in our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• Opportunity to thrive in a fast-paced, dynamic environment where you can influence company culture, wear multiple hats, and learn rapidly.

• Competitive compensation and benefits package, including base salary, performance bonuses, equity grant opportunities, and health, welfare & retirement benefits.

• Generous time off policy, including three weeks of PTO, two one-week company-wide shutdowns annually, and dedicated paid sick leave.

• Commitment to your professional growth with access to resources for further development.

• Apogee facilitates regular all-team, in-person meetings to foster relationships and collaboratively solve problems.