Job Title: Director, Biostatistics
Location: San Francisco Bay Area (Hybrid)
Company: Confidential (via Penfield Search Partners Ltd)
Employment Type: Full-time
Salary: $1/yr – $2/yr (indicative / placeholder range)
Industry: Biopharmaceutical / Clinical Research / Oncology
Company Overview
A clinical-stage biopharmaceutical company specializing in oncology is seeking an experienced Director of Biostatistics to lead statistical strategy and execution across all phases of global clinical trials. This hybrid role offers a highly competitive compensation package and the opportunity to work in a dynamic, science-driven organization.
Position Summary
The Director of Biostatistics will provide leadership in statistical design, analysis, regulatory strategy, and data management for clinical trials, with a focus on oncology. The role includes cross-functional collaboration, regulatory interaction, and oversight of CROs, with a strong emphasis on CDISC standards and FDA/EU compliance.
Key Responsibilities
Lead statistical design and analysis for clinical trials across all phases.
Develop and implement statistical strategies and standards for the department.
Review protocols, SAPs, case report forms, and ensure sound trial methodology.
Analyze data and collaborate with clinical teams on reporting and publications.
Oversee development and validation of integrated safety and efficacy summaries.
Represent the biostatistics function in regulatory interactions (FDA/EU).
Manage and evaluate CROs and vendors regarding deliverables, budgets, and quality.
Contribute to RFPs and scope-of-work documentation.
Ensure compliance with industry and regulatory standards including CDISC, FDA guidelines.
Required Qualifications
PhD in Biostatistics/Statistics with 8+ years OR MS/MA with 11+ years of industry experience.
Extensive background in clinical trials, preferably in oncology and within biotech/pharma.
Strong knowledge of CDISC (SDTM/ADaM), FDA/EU statistical regulations.
Proficiency in SAS and R.
Demonstrated experience interacting with health authorities.
Effective leadership and cross-functional communication skills.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
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Greece |North Island :
Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ireland | McFarland | Faridabad | Remote, USA | Minnesota | Remote | Thailand | Zaragoza | Remote - Middle East | Texas | Victoria | Belgium | Xzagreb | Medan | Melbourne | Nairobi | Hammond | Lenexa | Remote - Africa | Remote - South America (Latin Americal) | Green Way | Bountiful | Bishop | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Hungary | Springville | Manipal | French | Switzerland | Tulsa | Lousiana | Riga | Slovakia | Leinster | Castlebar |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Prague |Chile :
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