This is a remote position that requires the candidate to be located in the United States.
About this role
The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs.
This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management. This includes communication and quality oversight of the vendor. He/She is comfortable representing the Statistical Programming perspective to the study team or Clinical Development Team and is often the sole functional representative.
The Senior Principal Analyst, Statistical Programming helps to implement the Data and Programming Strategy, provides input to the Data Standards personnel and DM on the strategic direction of the program, partners with the PL to ensure appropriate statistical programming standards implementation and serves as reference for the study to Data Standards personnel. He/She develops and implements standard programming practices while also ensuring that they are employed across a study or program. He/She collaborates on tools and process improvement for Statistical Programming.
What you’ll do
Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight.
Considered a statistical programming expert within the department. Authors CDISC ADaM (analysis data model) analysis 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 through 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.
Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON.
Serves as the Statistical Programming Lead to achieve milestones for a drug program; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs.
Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan.
Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
Who you are
You are a senior principal analyst with strong statistical programming skills to effectively lead and collaborate across functions. You pay close attention to detail and have the proven ability to manage some competing priorities. You believe in and live by Biogen’s culture essentials in pioneering, think broadly, drive results, ethical and inclusive.
Required Skills:
· Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred.
· 10 years relevant work experience within an organization with a focus on data management and analysis.
· 10+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO.
· 10+ years relevant industry experience.
· 10+ years clinical trial experience.
· 5+ years clinical database experience.
· CDISC and/or submissions experience.
· Extensive knowledge of drug development process and clinical trials.
· Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.
· Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages).
· Familiarity AI and ML concepts.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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