Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking an experienced Contract Sr. Manager, Statistical Programming who will be primarily responsible for the development and validation of statistical programs for late-stage clinical studies. This role ensures programming activities comply with SOPs and regulatory requirements to produce high-quality and timely deliverables.
Responsibilities:
- Lead the development and validation of statistical programs to produce high-quality deliverables for in-house and outsourced projects, ensuring compliance with company and regulatory requirements.
- Support ISS/ISE analyses for NDA submissions.
- Assist with project work to ensure timely, high-quality delivery across studies.
- Create and review programming plans and specifications for datasets and TLFs. Requires advanced knowledge of CDISC standards, including SDTM and ADaM models, with experience in implementing these models.
- Review documents produced by biometric functions, such as SAP, CRFs, data review plans, and data transfer agreements.
- Review and validate deliverables produced by CROs, including SDTM, ADaM, and TLFs, and provide solutions to issues raised by CROs.
- Review e-submission datasets and data documentation, including aCRFs, reviewer guides, define.xml documents, and programs to ensure all files meet submission requirements.
- Develop macros to support study and project activities, improving overall efficiency and capacity of the programming function.
- Stay current with ICH guidelines and maintain advanced knowledge of submission requirements and standards.
- Support the preparation of clinical study reports, regulatory submissions, annual DSURs, and safety reports for multiple studies.
- Effectively communicate within the project team environment, across departments, and with external collaborators.
The Ideal Candidate
- Expert-level SAS programmer with experience delivering complex programming assignments and analyses. Proficient in developing original code, including macros, as well as modifying existing code.
- Advanced knowledge and extensive hands-on experience with CDISC standards, such as CDASH, SDTM, and ADaM.
- Experience in the drug development process and working with CROs.
- Experience with FDA/EMEA/CDE filings.
- Strong interpersonal and effective communication skills (oral and written).
- Thorough attention to detail and consistency.
Education Requirement
- Bachelor’s degree or equivalent education, preferably in a computational or biological science, with a minimum of 8 years of directly related experience in a drug development environment.
- Or a Master’s degree with a minimum of 6 years of related experience.
This is a primarily remote contract position.
Contractor perks include:
- Free access to Genentech Bus & Ferry Share program
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.
Top Skills
What We Do
At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies.
We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects.
Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction.
Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.
