About This Role

The Associate Director, Statistical Programming reporting to Statistical Programming & Clinical Data Sciences Lead, Biogen 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.

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.

Required Skills

BA/BS

12 years relevant work experience within an organization with a focus on data management and analysis

12+ years SAS Base programming with 7+ years using SAS STAT, GRAPHand MACRO

12+ years relevant industry experience

12+ years clinical trial experience

10+ 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

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

Preferred Skills

Experience with R is a plus

Job Level: Management

Additional Information:

The base compensation range for this role is: $176,000.00-$242,000.00
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.