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Senior Director, Statistical Programming

DirectorDirectorFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

78 days ago

Salary

$270K - $295K / year

Seniority

Senior

Postgraduate Degree12 yrs expEnglishCloud

Job Description

Senior Director, Statistical Programming

Apogee Therapeutics

• 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

Job Requirements

  • 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

Benefits

  • 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
  • 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

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