Senior Director, Head Of 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!   We are seeking an accomplished and strategic Senior Director, Head of Statistical Programming, to lead our statistical programming team, reporting into VP, head of Biostatistics and Programming. This role will be crucial in steering the development and implementation of statistical programming activities, ensuring the delivery of high-quality, regulatory-compliant statistical outputs. The position requires a broad, comprehensive, and detailed knowledge of Statistical programming languages and software, NDA/BLA filing requirements, clinical trial databases, and pharmaceutical drug development process. The incumbent will manage a group of programmers who develop statistical programs that generate analysis datasets, produce outputs for tables and graphs, validate statistical programs, write general SAS application codes, prepare documentation for electronic submissions, and explore new technologies to enhance quality and productivity of analytical programming.

Key Responsibilities

• Management of the Statistical Programming Team according to Alector’s values including development of the staff and the department to meet Alector’s business needs
• Provide visionary leadership and direction to the statistical programming team, fostering a culture of innovation, excellence, and continuous improvement.
• Develop and execute strategic plans for statistical programming in alignment with company objectives and regulatory requirements.
• Serve as a key member of the leadership team, contributing to the overall strategy and direction of the clinical development programs.
• Provide leadership and project coordination to all statistical programmers working in the project, including in-house FTEs, consultants and statistical programmers at CROs
• Prepare the clinical components of regulatory submissions, e.g. Clinical Overviews, Summaries of Clinical Efficacy and Safety, Briefing documents, regulatory response documents, Clinical Study Reports and Investigator’s Brochures
• Ensure communication of a clear, concise, complete, credible and compelling scientific content aligned with the objective of a regulatory document
• Support clinical studies with programming skills
• Support and drive company projects, data and programming standards together with the Head of Biostatistics and Programming
• Recruit, mentor, and manage a team of skilled statistical programmers, ensuring ongoing professional development and technical expertise.
• Define clear roles, responsibilities, and performance metrics for the team, promoting accountability and high performance.
• Foster a collaborative and supportive work environment, encouraging effective communication and teamwork across departments.

Scope of the Job:

• Ensure timely and accurate delivery of statistical outputs, including datasets, tables, listings, and figures for clinical study reports and regulatory submissions from Statistical Programming in accordance with project milestones and in line with the overall Alector project portfolio priority
• Responsible for processing of clinical data required for analysis of clinical trials, Phase I-IV.
• Create/acquire tools to improve programming efficiency or quality.
• Oversee the development, validation, and maintenance of statistical programs and datasets, ensuring accuracy, consistency, and compliance with industry standards.
• Support data request from other functional group (Statistical Science, Medical Writing, Drug Safety, Regulatory and Medical Affairs).
• Develop and implement standard operating procedures (SOPs) and best practices for statistical programming activities.
• Act as mentor for junior staff by giving lessons, advices and challenging their SAS code

Quality and Compliance:

• Ensure all statistical programming activities comply with regulatory requirements, industry standards (e.g., CDISC, SDTM, ADaM), and company policies.
• Lead initiatives to improve data quality and integrity, implementing robust quality control measures and promoting a culture of continuous improvement.
• Act as the primary contact for internal and external audits related to statistical programming.

Collaboration and Communication:

• Collaborate closely with biostatisticians, data managers, clinical operations, and regulatory affairs to ensure seamless integration of statistical programming efforts.
• Communicate complex statistical programming concepts and data-related issues to non-technical stakeholders in a clear and concise manner.
• Represent the statistical programming function in interactions with regulatory agencies, partners, and external vendors.

QUALIFICATIONS

• Education/Learning Experience

• Required:

• Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.

• Desired:

• Master of Science (MSc) or PhD

• Work Experience

• Required:

• A minimum of 12-year experience of drug development within pharmaceutical industry and/or a Contract Research Organization (CRO)

• Experience of leading regulatory submissions for NDA/BLA with FDA or EMA

• Excellent written and verbal communication skills in English

• Desired:

• A minimum of 8 years of experience of Statistical Programming or similar

• Successful track record of leading complex projects

• A minimum of 5 years of experience in managing statistical programmers

• Skills/Knowledge

• Required:

• Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment, in particular clinical trial data setting and clinical submissions (Base SAS, SAS Macro and SAS Graph)

• Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies, and knowledge or experience using these models

• Familiar with common external coding dictionaries (MedDRA and Standard MedDRA Queries, SMQ and WHO DD), knowledge or some experience of other external dictionaries (e.g. SNOMED, WHOART, COSTART and UNII)

• Excellent oral and written communication skills

• Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results

• Desired:

• Extensive knowledge in CDISC data standards and controlled terminology

• Excellent application and macro development skills

• Personal Attributes

• Required:

• Highly developed analytical and strategic thinking with an ability to identify key issues

• A strong great teammate, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds

• Sense of accountability and ownership and able to work independently

• Good project management and organizational skills

• High scientific and ethical integrity

• Curiosity and drive to broaden skill and knowledge

• Desired:

• Excellent leader with strong interpersonal and influencing skills

• Languages

• Required: English, both oral and written communication