Director, Statistical Programming

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history 
Please join us in driving the development of new therapies that seek to transform patients' lives. If autonomy and collaboration in tackling challenges is what you are seeking and would like to be part of a hardworking team where everyone has a voice, please join in our mission!
Reporting to the Head of Statistical Programming, the Director of Statistical Programming is responsible for successful execution of study-level, compound level deliverables and achievements over the drug development life cycle in addition to leading various initiatives for department improvements. The position requires a broad, comprehensive, and detailed knowledge of programming languages and software, filing requirements, clinical trial databases, and pharmaceutical drug development process. The incumbent will manage a group of programmers who develop programs that generate CDISC compliant SDTM & ADaM datasets, TLFs and a variety of reports to facilitate the review of clinical data & validate such programs, write general SAS application codes, prepare documentation for electronic submissions, and explore new technologies to enhance quality and productivity of statistical programming group. You will work closely with the Head of Statistical Programming to assign resources for various projects based on priorities and to foster business relationships internally and externally. You will also contribute to establishing standards for the statistical programming group including templates for SDTM, ADaM and TLFs specifications.

Key Responsibilities:

• In accordance with all applicable statistical regulatory guidelines and standards, leads or supervises the work of statistical programming in support of clinical trials, regulatory submissions, publications, and ad hoc analysis requests for all Alector development projects.
• Oversees the deadlines for statistical programming in order to plan and synchronize deliverables with the study's overall schedule.
• Adhere to CDISC (Clinical Data Interchange Standard Consortium) guidelines and best practices to create or oversee the creation of SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) compliant datasets.
• Participate in study meetings with Clinical science, Clinical operations, Data management, Safety and Statistical teams to create specifications and develop reports.
• Create DOS/UNIX batch script to schedule SAS jobs and distribute the reports to corresponding clinical team.
• Contributes to the development of SOPs and other departments and/or cross functional initiatives.
• Contributes to decisions regarding the technical infrastructure of statistical programming and works with IT to ensure local IT infrastructure meets statistical programming needs and global standards
• Oversees the work of internal FTEs and/or contract programmers, provides guidance, and mentoring to programmers. Be responsible for career development of junior programmers.
• Stay current with regulatory requirements on CDISC and clinical regulatory programming standards including therapeutic area-specific standards.
• Evaluate CDISC electronic data packages for completeness and ensure submission readiness of study data packages per CDISC standards and FDA guidelines.
• Participates as needed in strategy discussions and decisions to successfully accomplish business goals with creative solutions wherever possible.

Requirements:

• A M.S.(or higher) in Statistics, Computer Science or other closely related field to programming with minimum 10+ years of relevant pharmaceutical/biotech industry experience.
• Prior neuroscience & oncology/hematology experience highly desirable.
• Dynamic self-starter; agile learner; strategic and creative problem solver.
• Demonstrated strong problem solving and risk-mitigation skills.
• Requires solid knowledge of statistical programming principles, clinical trials process and regulatory requirements
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
• Able to communicate and collaborate effectively with cross-functional teams (clinical operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email
• Good solid understanding of ICH, FDA, and GCP regulations and