- Responsible for oversight of all aspects of the statistical programming function
- Sets functional and employee goals. Conducts performance reviews. Mentors and provides professional learning and development opportunities for staff.
- Defines, develops and implements procedures, work instructions, and functional policies for good programming practices, with continued improvement.
- Ensures adherence to FDA and global regulations regarding training records, guidelines and SOPs.
- Stay current on emerging regulations, requirements and guidance that relate to data submission standards by the FDA and other health authorities.
- Identifies strategic needs in technical knowledge and builds capabilities for the function.
- Maintains effective communication with biostatistics, data management, clinical operations, and clinical development teams.
- Exercises independent judgment. Acts independently to determine methods and procedures on new assignments.
- Designs, develops, evaluates, validates, and continues to improve the biometrics computing environments and programs (such as SAS and R) for the analysis and interpretation of clinical trial data.
- Manages creating CDISC SDTM and ADaM files, SAS transport files and used for electronic submission with data from EDC as well as data in non-standard form from various data sources.
- Manages the activities of data review, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Be able to work on multiple tasks and prioritize tasks for team members to meet timelines on a regular basis.
- Reviews data management study documents such as Data Management Plan, Edit Check Specifications and eCRF UAT.
- Interacts with statisticians and members of clinical team, performs ad hoc analysis, and generates outputs according to the requirements.
- Implements statistical analysis plans; provides additional expertise in the programming and analysis of clinical trial as it relates to protocol development, case report form design, and data collection.
- Creates/acquires tools to improve programming efficiency or quality.
- Establishes monitoring of clinical and safety data trends for ongoing trials as appropriate to identify study conduct or data quality issues, or drug safety concerns.
The ideal candidate - Master or higher degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related scientific discipline.
- Minimum 12 years of analytical programming experience in the biotech/pharmaceutical industry, including track record of successful project and people management.
- Experience building out a statistical programming function in a small biotech environment is highly preferred.
- Ability to cultivate relationships and negotiate with cross-functional leaders and peers.
- Ability to efficiently allocate resources to manage multiple clinical programs with competing priorities.
- Self-motivated, flexible and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment. Ability to use professional concepts to achieve objectives and solve problems.
- Strong communication skills: oral, written, with proven negotiation skills, and strong time-management.
- A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations.
- Experience working with immunology trials and NDA submission experience is highly desirable.
- Strong SAS programming and statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat. SAS certification is highly desirable.
- Experience with R or Python for clinical trial monitoring and/or safety signal detection is a plus.
- Sound and practical understanding of evolving technologies in support of all business areas and needs.
- Advanced knowledge of drug development across all stages, with the ability to understand and interpret data/information and its practical application.
- Experience managing external vendors.
Education- Master or higher degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related scientific discipline.
Alumis Values- Elevate
- Challenge
- Nurture
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 $255,000 USD to $280,000 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.
- Master or higher degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related scientific discipline.
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Senior Director, Head of Statistical Programming - South San Francisco, United States - Alumis Inc.
Description
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 Director, Head of Statistical Programming, who will be responsible for planning, managing, and overseeing the statistical programming activities for all clinical programs at Alumis. He/she will be responsible for coordinating external programming vendors and FSPs with internal programming teams and cross-functional teams to ensure corporate, departmental, and functional goals are achieved. He/she will formulate the strategies and oversee the implementation of statistical programming to ensure optimal support and on-time deliverables with quality on clinical program milestones. Furthermore, this person will set the direction identify areas of growth for the function, and establish strategic and operational plans to build these capabilities.
This role will supervise a team of statistical programmers/analysts/data scientists and be accountable for hiring and onboarding new employees for the function. The ideal candidate is expected to demonstrate effective leadership and collaboration with cross-functional partners.
This is an onsite hybrid position reporting to the Vice President, Head of Biostatistics and Statistical Programming.
Responsibilities
Senior Director, Head of Statistical Programming professionals in South San Francisco
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Kuo-Ching Chang
Data Scientist