Associate Director, Statistical Programming

Company Description

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

Job Description

About This Role

The Associate Director, Statistical Programming will be reporting to the Statistical Programming & Clinical Data Sciences Lead for Biogen's West Coast Hub. He/She will lead and oversee statistical programming activities of internally and externally through vendors, ensure all statistical programming deliverables in adherence to company SOPs and ICH/GCP. This person leads an indication of a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management. He/She develops and implements standard programming practices while also ensuring that they are employed across a program/Therapeutic Area.

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
• Provides statistical programming expertise within Biogen, including demonstrated proficiency in CDISC SDTM (Study Data Tabulation Model) and CDISC ADaM (Analysis Dataset model) implementation. Authors analysis data set specifications including the identification of potential data issues or areas of critical data examination.  Engages with Biostatistics to define and document programming endpoint 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 in SSM 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 QPT
• Serves as the Statistical Programming Lead to achieve milestones for an indication of a drug program/Therapeutic Area; 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
• Aligns internal and external project team members on statistical programming requirements, deliverable status, and resource needs

Who You Are

You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration.

Qualifications

• 15+ years relevant work experience within an organization with a focus on data management and analysis required.
  • 15+ years SAS Base programming, with 7+ years using SAS STAT, GRAPH and MACRO required.
  • 15+ years relevant pharma/biotech industry experience required.
  • 15+ years clinical trial experience required.
  • 10+ years clinical database experience required.
  • CDISC and/or submissions experience required.
• Extensive knowledge of drug development process and clinical trials required.
• Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines required.
• Familiarity with UNIX required.
• Strong management skills, and ability to effectively lead and collaborate with all functions.
• High attention to detail including proven ability to manage multiple, competing priorities.
• Experience with R is preferred.

Additional Information

The base compensation range for this role is $155,000 - $258,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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.