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 Senior Manager, Statistical Programming to drive the development and validation of statistical programs for late-stage clinical studies. In this role, you will ensure programming activities align with SOPs and regulatory requirements, delivering high-quality and timely results. This is an exciting opportunity to contribute to critical drug development efforts while driving efficiency and compliance in statistical programming.
RESPONSIBILITIES
- Lead the development and validation of statistical programs to ensure high-quality deliverables for both in-house and outsourced projects, adhering to company and regulatory requirements.
- Drive ISS/ISE analysis tasks in support of NDA submissions.
- Assist in planning and coordinating project work to ensure timely and high-quality delivery across multiple studies.
- Develop and review programming plans, dataset specifications, and TLFs; apply expertise in CDISC standards, including SDTM and ADaM models.
- Review documents produced by biometric functions such as SAPs, CRFs, data review plans, and data transfer agreements.
- Oversee CRO programming activities, reviewing and validating CRO deliverables including SDTM, ADaM and TLFs, while providing solutions to any issues raised by CROs.
- Review eSubmission datasets and data documentation such as aCRF, reviewer guides, define documents and programs to ensure all files meet submission requirements.
- Develop macros to support study and project activities, contributing to global macro tools that enhance the overall efficiency and capacity of the programming function.
- Maintain deep familiarity with ICH guidelines and advanced knowledge of regulatory submission requirements, ensuring all statistical programming deliverables meet industry and company standards.
- Support the preparation of clinical study reports, regulatory submissions, DSURs, and safety reports across multiple studies.
- Contribute to the development, implementation and continuous improvement of programming processes and standards.
- Communicate effectively within project teams, across departments, and with external collaborators.
THE IDEAL CANDIDATE
- Expert-level SAS programmer with a proven track-record of delivering complex programming assignments and analyses.
- Skilled in writing original cold, developing macros and modifying existing code.
- Experience in developing and implementing statistical programming standards and procedures.
- Expert level knowledge and extensive hands-on experience with CDISC standards including CDASH, SDTM, and ADaM.
- Experience leading teams supporting FDA, EMEA, and CDE regulatory filings.
- Strong interpersonal skills with excellent written and verbal communication.
- Meticulous attention to detail and consistency.
EDUCATION
- Bachelor’s degree (or equivalent), preferably in a computational or biological science, with a minimum of 8 years of direct experience in drug development.
- Master’s degree with minimum of 6 years of related experience.
This position is located in South San Francisco, CA. At this time we are not considering remote applicants.
The salary range for this position is $180,000 - $210,00 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer.
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.
