Associate Director Statistical Programming
Associate Director Statistical Programming
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Job Description
The Associate Director Statistical Programming will be accountable and responsible for leading statistical programming activities for multiple clinical studies maintaining programming infrastructure and ensuring timely deliverables with high quality. You also will perform oversight on the counterpart from vendors. You will report to the Senior Director Statistical Programming.
You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and indepth understanding of CDISC standards and drug development principles in solid tumor therapeutic area.
- Collaborate closely with Biostatistics Data Management Medical Safety Clinical Research Clinical Operation and other functions within Bicycle Therapeutics to address their needs for statistical programming support
- Develop and validate programming specifications for table listing and figure
- Develop and validate SAS program that generates table listing and figure
- Apply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF SDTM mapping specification and ADaM specification
- Develop and validate SAS program that generates SDTM and ADaM dataset
- Create and validate files necessary to support electronic submission in eCTD format
- Conduct statistical programming and/or statistical simulations to support clinical decision making regulatory interaction and publication
- Support development of CRF edit check review of Data Transfer Specification and any other collaborations with Data Management function
- Effectively manage external vendors
Qualifications :
- Good Clinical Practice (GCP) proficient
- Broad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies preferably in Oncology therapeutic area
- Proficient programming skills using SAS. Indepth experience on BASE SAS SAS/STAT SAS Macro
- Ability to independently manage multiple projects strong problemsolving skills and excellent teamwork spirit
- Effective SAS techniques in efficacy and safety analysis of solid tumor clinical studies
- Excellent communication skills both written and verbal
Additional Information :
- Flexible working environment
- Competitive reward including annual company bonus
- Medical dental and vision insurance for eligible employees and their families with 100 of the premiums covered by the Company
- Health and Dependent Care Flexible Spending Accounts
- 401(k) plan with a 4 Company match and immediate vesting
- Eligibility to accrue up to 23 paid time off days per full year worked plus the option to buy up to 5 additional days
- Employee assistance program
- Employee recognition schemes
- 10 Company holidays
- Competitive Family Leave Policy
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore all qualified applicants will be considered for employment and we do not discriminate on the basis of race religion colour gender sexual orientation age disability status marital status or veteran status.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
