Associate Director, Statistical Programming

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received over $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

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:

• 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 interface applications, 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 9+ years in a programming or statistical role.
• 3+ years of experience in line management or equivalent leadership experience, such as management. Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met.
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
• 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.  R programming, Spotfire knowledge and experience is a plus.
• Experience with regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards.
• 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 in contributing to Statistical Analysis Plans, Data Management plans, Programming SOPs, work instructions and developing technical programming specifications.
• Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs.

• 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.
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
• NDA submission experience is required.
• 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.

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.

COVID Safety:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster.  The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations.  The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

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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