The Role:
We are seeking an experienced hands on statistical programming expert to join our team. In this role you will be partnering with head of clinical and statistical programming to set standards, ensuring compliance based on CDISC standards, overseeing the work provided by external CRO partners and internal contractors, taking ownership of programming deliverables, supervising and mentoring programming staff, allocating resources effectively, identifying gaps and implementing improvements in programming and infrastructure, resolving issues related to clinical and translational data, and upholding company values through excellence, teamwork, innovation, respect, and accountability. You will collaborate closely with clinical study team including biostatisticians, data managers, CROs, Clinical scientists, translational scientists, SMEs from Clinical operations, Pharmacovigilance, Quality, and IT on various tasks.
This is an exciting opportunity for a visionary individual who is ambitious, detail-oriented, and passionate about advancing statistical programming to drive innovation in clinical research. If you are eager to develop cutting-edge programming solutions, optimize data analysis, and contribute to impactful advancements in human health, this role is for you. This position can be remote or onsite at our Somerville, MA location.
Here's how you will contribute:
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Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program.
• Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). 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 interfaapplications, to enhance the efficiency and capacity of the Statistical Programming group.
• Must be able to program defensively, check results, and consistently produce accurate output.
• 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 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.
The Ideal Candidate will have:
• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 10+ years of experience in Statistical programming, and Clinical programming.
• 3+ years of line management or equivalent leadership experience, with demonstrated ability to lead, mentor, and oversee multiple trials or programs simultaneously while meeting timelines and quality expectations.
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP).
• Advanced SAS programming expertise in a clinical trial environment, including Base SAS, SAS/STAT, SAS Macro language, and generation/validation of tables, listings, and figures (TLFs).
• Strong experience in development, validation, and review of SDTM and ADaM datasets, including specifications and submission-ready deliverables within a Statistical Programming environment.
• Advanced knowledge of regulatory requirements and industry standards, including FDA, EMA, ICH, and CDISC, with strong understanding of clinical trial data handling and submission expectations.
• 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.
• Significant experience contributing to or reviewing Statistical Analysis Plans, Data Management plans, Programming SOPs, work instructions and programming specifications.
• Strong experience developing and maintaining standard programs, reusable macros, and programming utilities to improve quality, consistency, and efficiency.
• At least 3+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including coordination of internal and/or external programming teams.
• Experience outsourcing programming activities and providing oversight of CROs, vendors, and contractors, including deliverable review, timeline management, and quality oversight.
• NDA submission experience is required.
• Experience with R programming, Spotfire visualization, and/or Generative AI tools for analytics, visualization, automation, or process improvement is a plus.
• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders.
• The ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands.
• Skilled at planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure.
About Generate:Biomedicines
We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.
Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.
At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
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