Associate Analyst, Statistical Programming
Durham County, NC - USA
Job Summary
About this role
The Associate Analyst Statistical Programming supports statistical programming activities across clinical studies including analysis datasets tables listings figures and regulatory submission deliverables. The role partners with Biostatistics and Data Management to produce high-quality submission-ready outputs. This position contributes to study timelines supports implementation of data standards and assists in resolving data and programming issues under supervision.
What youll do
- Support coordination delivery and review of statistical programming outputs across assigned studies
- Develop CDISC ADaM analysis datasets and specifications; identify and flag data quality issues
- Contribute to end-to-end programming from CRF data collection through regulatory submission
- Support preparation of submission deliverables ( XPTs reviewer documentation)
- Collaborate with Biostatistics Data Management and Data Standards to ensure consistency and compliance
- Assist with process improvement initiatives and departmental efficiency efforts
Who you are
- Detail-oriented with ability to manage multiple priorities
- Collaborative and comfortable working cross-functionally
- Able to communicate progress risks and issues clearly
- Interested in applying statistical programming standards in a clinical environment
Required skills
- Bachelors degree in Statistics Mathematics or related field
- 02 years of SAS programming experience (Base STAT GRAPH MACRO)
- Exposure to clinical trials data management or statistical analysis
- Basic knowledge of CDISC standards and clinical data structures
- Understanding of drug development process and regulatory requirements
Preferred skills
- Masters or PhD in Statistics Mathematics or related field
- Experience with regulatory submissions (e.g. SDTM/ADaM datasets)
- Familiarity with R UNIX or other statistical programming tools
- Knowledge of ICH/FDA guidelines and submission standards
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 $10000 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 onto learn more about our Biogen.
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.
Required Experience:
IC
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more