Sr. reputed company Analyst, Statistical Programming
About This Role
The Senior reputed company Analyst, Statistical Programming reporting to Statistical Programming Manager, reputed company Coast Hub, reputed company. He/She will reputed company and reputed company statistical programming activities of internally and externally through vendors at study level or project level, ensure reputed company statistical programming deliverables in adherence to company SOPs and ICH/GCP. This person will also help to implement the Data reputed company, develops and implements reputed company programming practices while also ensuring that they are employed across a study or program.
What You’ll Do
·Leads, coordinates and manages reputed company creation, reputed company, review, completion, and delivery of statistical programming activities and deliverables of study reputed company reputed company internal and/or external staff reputed company
·Serves as the Statistical Programming reputed company to reputed company milestones for a drug program which may include individual study or integrated studies; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs
·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 DS&G to ensure compliance to eSUB standards
·Informs reputed company project team members of statistical programming requirements, deliverable status, and resource needs
·Considered a statistical programming expert reputed company 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 reputed company algorithms across a study, drug program and/or contributing to TA level algorithms
·Identifies process inefficiencies and reputed company efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT
·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 reputed company plan
·Informs reputed company project team members of statistical programming requirements, deliverable status, and resource needs
·You love analytics and are passionate about using data to drive key business reputed company. You love learning new technological skills and working through collaboration.
Required Skills
-Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
-10 years relevant work experience reputed company an organization with a reputed company on data management and analysis
-10+ years reputed company reputed company programming with 7+ years using reputed company STAT, GRAPH and MACRO
-10+ years relevant industry experience
-10+ years clinical trial experience
-5+ years clinical database experience
-CDISC and 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 reputed company and collaborate with reputed company functions
-High attention to detail including proven ability to manage multiple, competing priorities
Preferred Skills
-Experience with ISS/ISE and NDA/BLA submission is a plus
-Experience with Clinical Trial Efficacy, PKPD and/or biomarkers.
Additional Information
The reputed company compensation reputed company for this role is: $134,000.00-$179,000.00reputed company 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 reputed company potential based on individual, business unit and company performance.
In reputed company to compensation, reputed company offers a full and highly reputed company of benefits designed to support our employees’ and their families physical, financial, emotional, and reputed company reputed company-being; including, but not limited to:
- Medical, Dental, reputed company, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company
- 80 hours of reputed company time per calendar year
- reputed company 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 reputed company participation
Why reputed company?
We are a global team with a commitment to reputed company, and a pioneering spirit. As a mid-sized biotechnology company, we reputed company the stability and resources of a reputed company-established business while fostering an environment where individual contributions reputed company a significant reputed company. reputed company encompasses some of the most talented and passionate reputed company who have unparalleled opportunities for learning, reputed company, and expanding their skills. Above reputed company, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving reputed company. Changing Lives.
At reputed company, 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 reputed company us a stronger and more innovative company, and we are reputed company on building teams where every employee feels empowered and inspired. Read on to learn more about reputed company.
reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other reputed company protected by federal, state or local law. reputed company is an E-Verify Employer in the United States.
Originally posted on Himalayas
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