Associate Director Statistical Programming
Associate Director Statistical Programming
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Salary Not Disclosed
1 Vacancy
Job Description
About This Role
The Associate Director Statistical Programming will be reporting to the Statistical Programming & Clinical Data Sciences Lead for Biogens 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 Youll 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 endtoend programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (eSUB) components (input to reviewers 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 $155000 $258000. 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 Biogens LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
