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Associate Director, Statistical Programming

2 months ago
United States
Full-time
Lead
Data Scientist
Data Science and Analytics
R SAP
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 20

Description

  • Serve as lead statistical programmer on one or more clinical studies.
  • Provide statistical programming oversight to programming vendors and CROs.
  • Review and validate datasets and TFLs programmed by external vendors.
  • Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver data deliverables on time.
  • Develop and implement data review and reporting tools and other statistical applications with cross-functional partners.
  • Participate in developing and implementing statistical programming processes and standards.
  • Review study documents such as SAP, DMP, CRF, annotated CRF, and TFL specifications and provide expert feedback.
  • Build and mentor a team of programmers supporting clinical trials and pipelines.
  • Generate ad hoc analyses on an ongoing basis.
  • Support successful execution of clinical studies and submissions aligned to clinical goals.

Requirements

  • Master’s degree in Statistics, Biostatistics, Mathematics, Epidemiology, or a related discipline.
  • Minimum of 10 years of progressive, relevant clinical trial programming experience in the biotech/pharma industry.
  • Advanced SAS programming skills and experience with other statistical software such as R.
  • In-depth knowledge of CDISC, including SDTM, ADaM, and controlled terminologies.
  • Experience managing CROs and other data vendors.
  • Knowledge of ICH guidelines and FDA, EMA, or other regulatory authority guidance.
  • Excellent organizational, prioritization, communication, and interpersonal skills.
  • Strong leadership skills with a growth mindset and commitment to a psychologically safe environment.
  • Ability to thrive in a fast-moving organization and work in a remote virtual environment.
  • Willingness to travel up to 15%, including mandatory in-person attendance at All Hands meetings twice per year.

Benefits

  • Anticipated salary range of $190,000 to $210,000.
  • Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Access to professional development resources and growth opportunities.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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