Head of Statistical Programming

We are looking for someone to lead and develop the North American team as well as providing mentoring, support and professional development to individual members of the Statistical Programming Team. In addition, work as Statistical Programmer providing communication skills and expertise in the preparation of regulatory, clinical, and marketing documents throughout drug development, post-marketing and life-cycle management.

Key Responsibilities

• Management of the US Statistical Programming Team according to Sobi’s values including development of the staff and the department to meet Sobi’s business needs
• Provide leadership and project coordination to all statistical programmers working in the project, including in-house consultants and statistical programmers at CRO
• 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 Statistical Programming
• Be the System owner for the new Statistical Programming Environment
• Collaborate with full SEDS to support and enhance project activities

Scope of the Job (define the job as it relates to the larger scheme of the organization)

• Ensure timely, high quality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi RDMA 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.
• Create/review programming plan, specifications for datasets and TLFs.
• Support data request from other functional group (Statistical Science, Medical Writing, MACD, Drug Safety, Regulatory and Marketing).
• Act as mentor for junior staff by giving lessons, advices and challenging their SAS code

Principal Interfaces / Relationships

List the titles of individuals with whom this position interacts, both inside and outside the organization.

Internal:

• Clinical Data Manager
• Product Statistician
• Study Statistician
• Statistical Programmer
• Medical Writer
• Clinical Program Leader
• Clinical Study Manager
• Medical Director Lead
• Medical Program Lead
• Drug Safety Manager and Physician
• Regulatory Affairs Manager
• Clinical Pharmacologist
• Marketing
• IT
• QA
• Patient Access

External:

• Programmers and other personnel at external service providers

Requirements

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 10-year experience of drug development within pharmaceutical industry and/or a Contract Research Organization (CRO)
• Experience of regulatory submission with FDA, EMA or PMDA
• Excellent written and verbal Communication skills in English

Desired:

• A minimum of 5 years of experience of Statistical Programming or similar
• Successful track-record of leading complex projects
• A minimum of 2 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 some 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 team player, 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

Desired: Swedish or French, both oral and written communication

Other Areas of Responsibilities: To participate in departmental activities, e.g. SOP writing, as required