Associate Director, Statistical Programming
Location
Cambridge, MA | United States
Job description
Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.
Culture is key and all Bicycle employees actively embrace and role model our company values:
- We are Adventurous . We believe it’s the way to deliver extraordinary results for our patients.
- We are Dedicated to our Mission . You can’t change the world if you don’t have determination.
- We are One Team . We only succeed when we work together.
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 Senior Director, Statistical Programming.
You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in Oncology 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 specification for table, listing, and figure
- Develop and validate SAS program that generate 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 generate 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
Qualifications
Essential:
- 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. In-depth experience on BASE SAS, SAS/STAT, SAS Macro
- Ability to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spirit
- Excellent communication skills, both written and verbal
Desirable:
Proficient in R programming
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.
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