Apogee Therapeutics

Associate Director, Statistical Programming

Apogee Therapeutics

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $190,000 - $210,000 per year

Job Level

Senior

About the role

  • 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

Requirements

  • 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
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingR programmingstatistical programmingdata review toolsstatistical applicationsCDISCSDTMADaMstatistical programming methodsdata validation
Soft Skills
organizational skillscommunication skillsinterpersonal skillsleadershipgrowth mindsetability to prioritize tasksmentoringcollaborationadaptabilitypsychological safety
Certifications
Master’s Degree in StatisticsMaster’s Degree in BiostatisticsMaster’s Degree in MathematicsMaster’s Degree in Epidemiology