Principal Statistical Programmer

Job Description

**About This Role**

In addition, you will also be responsible for providing input on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to his/ her counterpart and estimating resources needs.

He/She leads an external team of statistical programmers to accomplish tasks and communicate issues, as necessary, to colleagues and senior management. This includes communication and quality oversight of the vendor.

He/She is comfortable representing the statistical programming perspective to the Clinical Study Team (CST) or Clinical Development Team (CDT) and is often the sole functional representative.

**What You’ll Do**
- Leads, coordinates, and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of randomized clinical trials (RCTs) via internal and/or external staff oversight.
- Considered a statistical programming expert within Biosimilars Evidence Generation. Authors and reviews CDISC SDTM and ADaM data set specifications including the identification of potential data issues or areas of critical data examination. Works with Statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
- Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (eSUB) components (input to reviewer’s guides, annotated CRF, define and XPTs); works with SMEs to ensure compliance to eSUB standards.
- Process improvement in concordance with business needs.
- Serves as the Project Lead Statistical Programmer to achieve milestones for a biosimilar; evaluates task objectives, collaborates with Project Lead Statistician (PLS) and/or line manager on issues or resource needs.
- Conduct additional exploratory analysis, to further support evidence generation for multiple projects in different therapeutical areas.

**Who You Are**

You thrive working in a fast-paced environment where deadlines are tight and have strong attention to detail. You are passionate about making a difference and you collaborate to solve business challenges. You identify opportunities for improvement, you have the drive and you take the lead for such activities with determination.

Qualifications

**Required Skills**:

- MS or PhD in scientific, healthcare or other quantitative fields (e.g. statistics/ biostatics, mathematics, computer science, informatics, software engineering) preferred.
- 5+ years relevant industry experience.
- Proficiency in data handling using SAS, other statistical software (e.g. R) is a plus.
- Familiarity with UNIX is a plus.
- Knowledge of drug development and clinical trials.
- Extensive knowledge of drug submission requirements, relevant ICH (e.g. ICH-GCP, 21 CFR Part 11) and FDA/EMEA/ROW guidelines.
- Knowledge of other relevant guidelines for regulatory activities (e.g. ICH E3, ICH E8, ICH E9, E9(E1), ICH E10).
- eCTD/ submission experience.
- Excellent knowledge of CDISC standards, such as SDTM, ADaM and define.xml.
- Strong management skills, and ability to effectively lead and collaborate with all functions.
- Ability to communicate technical findings or topics to a non-technical audience.
- Ability to successfully work together with a (“virtual”) team.
- Multicultural experience.
- High attention to detail including proven ability to manage multiple, competing priorities
- Good project management and written/ verbal communication skills.
- Experienced managing and overseeing the outsourcing or externalization of statistical programming.
- Some relevant experience with simulation studies, e.g., for sample size calculation.

**Why Biogen?**

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Additional Information

The Biogen Biosimilars Unit (BBU) is committed to commercialization in several biologic categories and product launches. We are a team committed to advancing care for patients needing life changing therapies. As recent industry reports suggest, Biosimilar products in global healthcare have an opportunity to exceed billions of savings during the next five years - Biogen is committed to be at the forefront of this opportunity for patients and the healthcare system.