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Associate Director, Statistical Programming

DirectorDirectorFull TimeRemoteSeniorTeam 5,001-10,000H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

36 days ago

Salary

$176K - $242K / year

Seniority

Senior

Bachelor Degree12 yrs expEnglishUnix

Job Description

Associate Director, Statistical Programming

Biogen

• 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

Job Requirements

  • 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

Benefits

  • 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

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