Associate Director Statistical Programming

Provides communication skills and expertise in the preparation of regulatory clinical and marketing documents throughout drug development postmarketing and lifecycle management. Provides mentoring and support to individual members of the Statistical Programming Team being on the most expert in the field.

Drive and support company projects:

• Data and programming standards
• Enablement and finalisation of regulatory submissions regulatory response documents and other external clinical documents (e.g. publications) across multiple therapeutics area
• Inhouse database preparation and validation (e.g. Analysis datasets).
• Inhouse preparation and validation of output (Table Listing and Figure (TLFs)).
• Pooling strategy for integrated analysis (pooling of data ISE/ISS TLFs).
• Preparation review and finalization of regulatory document (e.g. Define.xml Reviewers guide ).
• Deep insight in CDISC standards.
• Provide strong technical programming support to Data Management. Prepare support and enable corporate clinical metadata external clinical dictionaries (e.g. CDISC CT MedDRA and WHO DD) and corporate standard reporting systems: SAS macro utility programs and associated tools.

Support clinical studies with programming skills:

• Review study documents (e.g. protocol CRF SAP and Clinical Study Report)
• Take ownership and provide sponsor oversight of outsourced studies to CROs
• Create/review programming documents (e.g. programming plan specification for datasets and output template)
• Work closely with Biostatistics to assure output quality by providing comments on SAP and output template
• Inhouse preparation and validation of adhoc report output working closely with the project and/or study statistician.
• Work closely with Data Management to assure data quality by providing adhoc QCanalysis.

Be the user representative for the internal Statistical programming data storing and computing environment:

• Provide user needs (Functional Requirements User Requirements System Design Specification) and changerequests.
• Source Code Handling Applications for Version control
• Define implement and perform user acceptance test scripts.
• Define and maintain needs and processes

• Ensure timely highquality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi R&D project portfolio priority
• Responsible for processing of clinical data required for analysis of clinical trials Phase IIV.
• Develop SAS coding for preparing processing and analysing clinical data.
• Generate and QC summary tables data listings and graphs for inhouse analyses of study data or publications using SAS standard coding practices. Validate work of other programmer/analysts.
• Create/request tools to improve programming efficiency or quality.
• Create/review programming plan specifications for datasets and TLFs.
• Support data request from other functional group (Biostatistics Medical Writing Clinical Development Drug Safety Regulatory and Marketing).
• Act as mentor for junior staff by giving lessons advice and challenging their SAS code

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 15year experience of Statistical programming in the biotechnology/pharmaceutical industry
• Experience of regulatory submission with FDA or PMDA
• Experience of regulatory submission with EMA
• Excellent written and verbal Communication skills in English

Desired:

• Successful trackrecord of leading complex projects

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
• Excellent application and macro development skills
• Extensive knowledge in CDISC data standards and controlled terminology

Desired:

• Extensive knowledge in settingup data or programming standard in formal companies

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:

• Track record of generating new ideas and solutions to data analysis

Languages

Required: English both oral and written communication

Desired: Swedish or French both oral and written communication

The base salary pay range for this role is $annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary this position is also eligible for a competitive 401k match short and longterm incentives medical dental vision STD/LTD and life insurance benefits in addition to other health and wellness programs and offerings.

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed firsthand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into groundbreaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to

COVID19 Policy

For the safety of our employees and all individuals with whom we interact professionally Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations as well as any statespecific exemptions as required by applicable law.