Head of Statistical Programming – US

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

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

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 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<