Associate Director, Statistical Programming

Summary

Join Generate:Biomedicines as an experienced statistical programming expert, partnering with the head of clinical and statistical programming to set standards and ensure compliance. You will lead statistical programming activities for multiple clinical trials, oversee external CRO partners and internal contractors, and manage programming deliverables. This role requires advanced SAS programming skills, experience with regulatory guidelines, and strong leadership abilities. The position offers the opportunity to contribute to impactful advancements in human health and can be remote or on-site in Somerville, MA. The ideal candidate will possess a BS/MS degree in a relevant field and 9+ years of experience in a programming or statistical role, including 3+ years of line management experience. Generate:Biomedicines is committed to equal employment opportunity.

Requirements

• Have a BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 9+ years in a programming or statistical role
• Have 3+ years of experience in line management or equivalent leadership experience, such as management
• Have demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met
• Have an in-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
• Have advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures
• Have experience with regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards
• Be expert in SAS and/or R programming, including creation of SDTM/ADaM specifications, development and validation of deliverables within a Statistical Programming environment, and the creation of advanced SAS macros and/or functions
• Have significant experience in contributing to Statistical Analysis Plans, Data Management plans, Programming SOPs, work instructions and developing technical programming specifications
• Have advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs
• Have at least 3+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers
• Have experience with outsourcing programming activities and overseeing services provided by CROs and contractors
• Have NDA submission experience
• Have excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders
• Have the ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands
• Be skilled at planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure

Responsibilities

• Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program
• Be accountable for timely and quality development and validation of all statistical programming components on assigned program(s)
• Be responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
• Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements
• Coordinate activities of internal / external programmers
• Make statistical programming decisions and propose strategies at program or indication/disease level
• Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s)
• Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries
• Manage the statistical computing environment, including folder structure and access control
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports
• Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams
• Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence
• Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications
• Collaborate with cross functional departments - Clinical operations, Translational science, Clinical science, Pharmacovigilance to gather the requirements and provide necessary outputs and analyses in SAS and Spotfire dashboards as per the requirement
• Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming group
• Be able to program defensively, check results, and consistently produce accurate output
• Be responsible for allocating resources within a program and ensuring resource sharing between programs
• Recruit, mentor, and develop statistical programmers and interns
• Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and be able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan)
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training
• Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC)
• Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives
• Adhere to FDA regulations regarding training records, guidelines, and SOPs
• Adhere to company SOPs/WIs and department guidelines

Preferred Qualifications

R programming, Spotfire knowledge and experience

Benefits

• Remote work
• Onsite work at Somerville, MA location