Principal Programmer at Sobi

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

07 May, 26

Salary

170000.0

Posted On

06 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SAS Programming, Statistical Programming, Regulatory Submission, CDISC Standards, Data Management, Clinical Trials, Project Management, Analytical Skills, Communication Skills, Team Collaboration, Data Quality Assurance, Programming Standards, Mentoring, Technical Support, Clinical Data Analysis, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

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 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 The Principal Programmer 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 finalization 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 Scope of the Job 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 analyzing 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 10-years 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 Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: A competitive 401(k) match to support your financial future. Tuition and wellness reimbursements to invest in your personal and professional growth. A comprehensive medical, dental, and vision package to prioritize your health and well-being. Additional recognition awards to celebrate your achievements. The base salary range for this role is $125,000– $170,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. 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 1,900 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. 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] Know Your Rights Sobi Location: United States

Responsibilities

The Principal Programmer is responsible for preparing regulatory, clinical, and marketing documents throughout drug development and providing mentoring to the Statistical Programming Team. They ensure timely, high-quality deliverables and support clinical studies with programming skills.