Statistical Programmer/Sr. Statistical Programmer

The Position

We are seeking a statistical programmer or sr. statistical programmer to join our growing biometrics team to support clinical studies across Arrowhead’s expanding portfolio. This is an exciting opportunity for a candidate trained in statistical methods and analysis who has some prior experience working as a statistical programmer, preferably within a CRO or a similar group. They will initially contribute their expertise in the area of statistical programming, with a goal to develop as a clinical trial statistician.

Responsibilities

• Develop targeted, study-specific SDTM and ADaM dataset checks
• Perform independent QC, from raw data to ADaM, of primary and key secondary endpoints
• Create draft output shells for ad-hoc requests, prepare analysis specs and scope
• Deliver programming results for ad-hoc analysis requests
• Review outputs provided by CROs for accuracy and consistency with the analysis plan and specs
• Review and contribute to the development of study SAP
• Collaborate with data management and their programming team to ensure appropriate data collection and reporting
• Participate in study team meeting and support statistician operational activities
• Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training

Requirements:

• Master’s degree in biostatistics/statistics/public health or similar field
• Basic understanding of clinical trials
• Working knowledge of SAS, including complex data manipulation and basic analysis procedures
• Interest in career development as a biostatistician in pharmaceutical industry
• Excellent verbal and written communication skills
• At least 1.5 years experience in statistical programming under the pharmaceuticals/bio-tech clinical development or CROs for the senior position.

Preferred:

• Familiarity with CDISC standards, derivation of SDTM and ADaM specifications
• Simulations and sample size calculation
• Proficiency in R
• Contributing to the writing of SAPs and related study documents
• CRO experience