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Associate Director Statistical Programming

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

Provides communication skills and expertise in the preparation of regulatory, clinical, and marketing documents throughout drug development, post-marketing and life-cycle 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
  • In-house database preparation and validation (e.g. Analysis datasets).
  • In-house 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, Reviewer’s guide …).
  • Deep insight in CDISC standards.
  • Provide strong technical programming support to Data Management. Prepare, support and enable corporate clinical meta-data, 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
  • In-house preparation and validation of ad-hoc report output, working closely with the project and/or study statistician.
  • Work closely with Data Management to assure data quality by providing ad-hoc QC-analysis.

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 change-requests.
  • Source Code Handling Applications for Version control
  • Define, implement and perform user acceptance test scripts.
  • Define and maintain needs and processes
  • Ensure timely, high-quality 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 I-IV.
  • Develop SAS coding for preparing, processing and analysing clinical data.
  • Generate and QC summary tables, data listings and graphs for in-house 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 15-year 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 track-record 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 setting-up 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 $151,000-227,000 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 long-term 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 Sobi's 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 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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 first-hand 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 ground-breaking 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 can’t 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 [email protected]

COVID-19 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 COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

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Average salary estimate

$189000 / YEARLY (est.)
min
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$151000K
$227000K

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What You Should Know About Associate Director Statistical Programming, Sobi

Join Sobi as an Associate Director of Statistical Programming in Morrisville, NC, where you'll have the opportunity to leverage your extensive experience in statistical programming to make a real difference in the lives of rare disease patients. At Sobi, we believe that a diverse team drives innovation and success, and we're looking for a passionate leader who can mentor and guide our Statistical Programming Team. In this role, you'll be responsible for everything from regulatory submissions to developing SAS programming solutions that streamline our clinical trial processes. With our commitment to quality, you'll also oversee the preparation, validation, and analysis of clinical data, ensuring timely delivery of high-quality outputs. Your leadership will enable our team to establish data as a key component in the decision-making process. Collaborating with cross-functional teams will be vital as you'll work alongside Biostatistics, Data Management, and other departments to produce comprehensive analyses and maintain data integrity. You can expect a competitive compensation package, generous time-off policy, and a work environment that emphasizes collaboration and work-life balance. So if you're driven by ambition and ready to tackle complex projects with a sense of urgency and ownership, we invite you to apply to join Sobi. Let's work together toward a healthier future for those living with rare diseases.

Frequently Asked Questions (FAQs) for Associate Director Statistical Programming Role at Sobi
What are the responsibilities of an Associate Director Statistical Programming at Sobi?

As an Associate Director Statistical Programming at Sobi, you'll be in charge of mentoring team members, overseeing regulatory submissions, and ensuring high-quality outputs from statistical programming. Your responsibilities include developing SAS codes, preparing and validating clinical datasets, and collaborating with various departments to maintain data integrity throughout clinical trials.

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What qualifications are required for the Associate Director Statistical Programming position at Sobi?

To qualify for the Associate Director Statistical Programming role at Sobi, candidates need a Bachelor of Science in fields like Computer Science, Mathematics, or Life Sciences, along with 15 years of experience in statistical programming within the biotechnology or pharmaceutical industries. Familiarity with CDISC standards and excellent SAS programming skills are essential.

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What skills are important for an Associate Director in Statistical Programming at Sobi?

Essential skills for the Associate Director Statistical Programming at Sobi include advanced SAS programming knowledge, project management capabilities, strong communication skills, and a thorough understanding of clinical trial data. You should also be a strategic thinker, adept in analytical tasks, and possess the ability to collaborate effectively with diverse teams.

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What is the work environment like for an Associate Director Statistical Programming at Sobi?

The work environment for an Associate Director Statistical Programming at Sobi is team-oriented and collaborative. Employees enjoy a culture that fosters innovation and continuous learning, with opportunities to attend conferences and further their professional development while contributing to impactful projects for rare disease patients.

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What benefits does Sobi offer for an Associate Director Statistical Programming?

At Sobi, the benefits package for an Associate Director Statistical Programming includes competitive compensation ranging from $151,000 to $227,000, generous time off, a robust 401k match, and various health and wellness programs. Employees can also enjoy summer Fridays and a strong emphasis on work/life balance.

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Common Interview Questions for Associate Director Statistical Programming
Can you explain your experience with SAS programming and how it applies to the role?

When discussing your SAS programming experience, focus on specific projects you’ve completed that involved complex data manipulations and analyses. Highlight how your SAS skills have facilitated successful regulatory submissions and provided high-quality outputs during clinical trials.

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Describe a challenging project you've led in statistical programming.

Share a specific instance where you faced significant challenges in a project, detailing your approach to address the obstacles. Emphasize your leadership skills, the collaborative strategies you employed with your team, and how you achieved successful outcomes.

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How do you ensure the quality of data used in clinical trials?

Discuss your methodologies for maintaining data quality, such as implementing validation checks, conducting ad-hoc QC analyses, and collaborating with Data Management teams. Illustrate how your proactive approach has safeguarded data integrity in past projects.

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What do you understand by CDISC standards, and how have you applied them in your work?

Clearly define CDISC standards and explain your familiarity with SDTM and ADaM models. Provide examples of how you've utilized these standards in previous projects to enhance regulatory submissions or improve data consistency.

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Can you provide an example of a time when you mentored a colleague or team member?

Reflect on a mentoring experience where you guided a junior programmer or analyst through a complex task. Explain the techniques you used to provide support and the skills you helped them develop, reinforcing the importance of teamwork in achieving project goals.

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What strategies do you employ for committing to deadlines in a project?

Discuss your project management skills and techniques you use to prioritize tasks, allocate resources effectively, and communicate with your team throughout the project process. Highlight any tools or methodologies that assist you in meeting deadlines.

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How do you stay updated with the latest trends in statistical programming and clinical trials?

Mention specific resources you frequently use, such as professional associations, attending conferences, online courses, and keeping up with relevant publications. Emphasize your commitment to lifelong learning and adapting to changes in statistical methodologies.

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What motivates you to work in the biopharmaceutical industry, especially with rare diseases?

Express your passion for making a positive impact on patients with rare diseases. Share personal stories or experiences that inspired you to pursue this career path and how they align with Sobi's mission and values.

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What is your approach to cross-functional collaboration?

Detail your experiences working with various teams, such as Biostatistics and Clinical Development. Share examples demonstrating your communication skills, how you build relationships, and how these collaborations contributed to successful project outcomes.

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How do you handle unexpected changes or setbacks in a project?

Discuss your adaptability in the face of changes, detailing your decision-making process when confronted with setbacks. Talk about the importance of being flexible while keeping the team informed and focused on objectives despite challenges.

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Our mission here at Sobi is to develop and deliver innovative therapies and services to improve life for people living with rare diseases.

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Full-time, on-site
DATE POSTED
January 8, 2025

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