Senior Manager, Statistical Programming

Job not on LinkedIn

November 14

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $140k - $196k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

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Generate Biomedicines

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Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

📋 Description

• Lead statistical programming activities for multiple clinical trials. • Accountable for timely and quality development and validation of all statistical programming components. • Produce and/or validate tables, listings, figures, and analysis datasets. • Coordinate activities of internal/external programmers and make statistical programming decisions. • Independently develop SAS or other programs for analyses. • Manage the statistical computing environment. • Work closely with Data Management and Biostatistics teams. • Manage CROs and contractors. • Collaborate with biostatisticians and clinical development colleagues. • Identify issues and develop global tools to enhance efficiency.

🎯 Requirements

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 7+ years in a programming or statistical role. • 2+ years experience in line management or equivalent leadership experience. • In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP) • SAS programming skills - procedures and options commonly used in clinical trials. • Experience with regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling. • Expert in SAS programming, including creation of SDTM/ADaM specifications. • Significant experience in contributing to statistical analysis plans and developing technical programming specifications. • Advanced knowledge of industry standards, including CDISC standards. • At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications. • Experience with outsourcing programming activities and overseeing services provided by CROs and contractors. • Excellent interpersonal skills with a proven ability to operate effectively in a global environment.

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package